10.14639/0392-100X-N2033
Objective. Otosclerosis is a frequent ear disorder causing a stapedo-ovalar ankylosis and conductive hearing loss. Stapedoplasty, performed under both general (GA) and local anaesthesia (LA), is the most advisable surgical solution. Auditory recovery relies on the patient’s conditions and on the intervention itself. The aim of our work was to compare hearing outcomes with stapedoplasty performed under GA or LA and to investigate patients’ compliance to both methods. Methods. Fifty-five otosclerotic patients underwent stapedoplasty both under GA (32/55) and LA (23/55). Pre- and post-operative air and bone tone audiometry threshold values as well as the air-bone gap and its closure score, were analysed. All patients filled in a satisfaction questionnaire regarding their concern and level of appreciation of the type of anaesthesia. Results and conclusions. Our data show that the auditory results with stapedoplasty are good and do not differ between LA and GA. Even considering the advantages and limits of the two methods, one cannot favour one or the other type of anaesthesia. Finally, the patient’s satisfaction cannot be considered a criterion of choice, since this was found to be high in both cases.
text/xml
1827-675X
2033
en
Rudi Pecci
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
stapes surgery
Hearing outcomes and patient satisfaction after stapes surgery: local versus general anaesthesia
Text.Serial.Journal
https://www.actaitalica.it/
42
Otology
2022-11-23
2022-02-08
2022-12-13
2022-12-13
471-480
1
Rudi Pecci
2022/11/23
10.14639/0392-100X-N2033
471
Unit of Audiology, Careggi University Hospital, Florence, Italy
1827-675X
stapes surgery
en
480
Hearing outcomes and patient satisfaction after stapes surgery: local versus general anaesthesia
https://www.actaitalica.it/article/download/2033/873
42
ACTA OTORHINOLARYNGOLOGICA ITALICA 2022;42:471-480; doi: 10.14639/0392-100X-N2033




Otology


Hearing outcomes and patient satisfaction after
stapes surgery: local versus general anaesthesia
Risultati uditivi e gradimento nei pazienti operati di stapedoplastica in anestesia locale
e generale
Beatrice Giannoni1,2, Federica Pollastri1,2, Chiara Adembri3, Dina Straticò1, Paolo Vannucchi1, Alessia Stival1,
Curzio Checcucci4, Chiara Bruno5, Rudi Pecci1
1
 Unit of Audiology, Careggi University Hospital, Florence, Italy; 2 Department of Neuroscience, Psychology, Drug’s Area and Child’s
Health, University of Florence, Florence, Italy; 3 Department of Experimental and Clinical Medicine, Unit of Anesthesiology, University
of Florence, Italy; 4 Department of Physycs and Astronomy, University of Florence, Italy; 5 Unit of Otorhinolaryngology, Careggi
University Hospital, Florence, Italy


SUMMARY
Objective. Otosclerosis is a frequent ear disorder causing a stapedo-ovalar ankylosis and
conductive hearing loss. Stapedoplasty, performed under both general (GA) and local an-
aesthesia (LA), is the most advisable surgical solution. Auditory recovery relies on the
patient’s conditions and on the intervention itself. The aim of our work was to compare
hearing outcomes with stapedoplasty performed under GA or LA and to investigate pa-
tients’ compliance to both methods.
Methods. Fifty-five otosclerotic patients underwent stapedoplasty both under GA (32/55)
and LA (23/55). Pre- and post-operative air and bone tone audiometry threshold values
as well as the air-bone gap and its closure score, were analysed. All patients filled in a
satisfaction questionnaire regarding their concern and level of appreciation of the type of
anaesthesia.
Results and conclusions. Our data show that the auditory results with stapedoplasty are          Received: February 8, 2022
good and do not differ between LA and GA. Even considering the advantages and limits             Accepted: June 1, 2022
of the two methods, one cannot favour one or the other type of anaesthesia. Finally, the
patient’s satisfaction cannot be considered a criterion of choice, since this was found to be    Correspondence
high in both cases.                                                                              Beatrice Giannoni
                                                                                                 Unit of Audiology, Careggi University Hospital,
KEY WORDS: stapedoplasty, otosclerosis, local anaesthesia, general anaesthesia, stapes           Florence, Department of Neuroscience, Psycho-
surgery                                                                                          logy, Drug’s Area and Child’s Health, University
                                                                                                 of Florence, viale Gaetano Pieraccini 6, 50139
RIASSUNTO                                                                                        Florence, Italy
                                                                                                 Tel. +39 055 7948154
Obiettivo. L’otosclerosi è una frequente patologia otologica che provoca anchilosi sta-
                                                                                                 E-mail: beatrice.giannoni@unifi.it
pedo-ovalare e ipoacusia trasmissiva. La stapedoplastica, eseguita in anestesia generale
(AG) o locale (AL), è la soluzione chirurgica ideale. Il recupero uditivo dipende da variabili
legate al paziente e all’intervento. Scopo del nostro lavoro è stato confrontare i risultati       How to cite this article: Giannoni B, Pol-
uditivi dopo stapedoplastica eseguita in AG e AL e indagare il grado di soddisfazione dei          lastri F, Adembri C, et al. Hearing outcomes
pazienti nei riguardi delle due metodiche.                                                         and patient satisfaction after stapes surgery:
Metodi. Abbiamo studiato 55 pazienti con otosclerosi sottoposti a stapedoplastica in               local versus general anaesthesia. Acta Otorhi-
                                                                                                   nolaryngol Ital 2022;42:471-480. https://doi.
AG (32/55) e AL (23/55). Abbiamo valutato la soglia audiometrica tonale pre- e post-ope-
                                                                                                   org/10.14639/0392-100X-N2033
ratoria, il valore del gap trasmissivo via aerea-ossea e la sua chiusura. I pazienti hanno
compilato un questionario di soddisfazione riguardo alla preoccupazione e al livello di
                                                                                                 © Società Italiana di Otorinolaringoiatria
apprezzamento del tipo di anestesia.                                                             e Chirurgia Cervico-Facciale
Risultati e conclusioni. I nostri dati mostrano che i risultati uditivi dopo stapedoplastica
sono buoni e non differiscono in base al tipo di anestesia. Anche considerando i vantaggi                       OPEN ACCESS
e i limiti delle due metodiche non si può propendere per la scelta dell’uno o dell’altro tipo
                                                                                                 This is an open access article distributed in accordance with
di anestesia. Infine, la soddisfazione del paziente non può essere considerata un criterio di
                                                                                                 the CC-BY-NC-ND (Creative Commons Attribution-Non-
scelta, poiché questa è risultata elevata in entrambi i casi.                                    Commercial-NoDerivatives 4.0 International) license. The
                                                                                                 article can be used by giving appropriate credit and mentio-
PAROLE CHIAVE: stapedoplastica, otosclerosi, anestesia locale, anestesia generale,               ning the license, but only for non-commercial purposes and
chirurgia stapediale                                                                             only in the original version. For further information: https://
                                                                                                 creativecommons.org/licenses/by-nc-nd/4.0/deed.en




                                                                                                                                                         471
B. Giannoni et al.




Introduction                                                      doplasty at the Audiology Unit of Careggi University Hos-
                                                                  pital in Florence between June 2016 and November 2017.
Otosclerosis is a dystrophic process of the otic capsule
                                                                  Thirty-two of 55 subjects underwent GA and 23 were oper-
characterised by an abnormal sponge-like bone growth at
                                                                  ated on under LA.
the middle-inner ear limit that often blocks the stapedo-
                                                                  Surgery was managed by the same “expert surgeon”, ac-
ovalar joint. At the beginning, hearing loss is solely con-
                                                                  cording to the definition given by Yang 7, in order to avoid
ductive, but becomes mixed and even pure sensorineural
                                                                  bias on comparing different surgical hands. All operations
with progression of the disease because of the extension of
                                                                  were with conventional footplate drilling and insertion of a
the pathological process into the cochlea 1,2.
                                                                  Teflon prosthesis. Anaesthesia was always administered by
The main treatment for otosclerosis is surgical, namely by
                                                                  the same anaesthesiology team that is specifically trained
stapedoplasty, which has the goal of restoring ossicular chain
                                                                  for otological surgery.
mobility and hearing performance by the partial or in toto
                                                                  Demographic data including age, sex and information on
substitution of the stucked stapes with a micro-prosthesis. In
                                                                  general pathological and otological history were collected.
the literature, the success rate of modern stapedoplasty has
                                                                  The type of anaesthesia used during the operation, audio-
been reported to be 75-94% in terms of hearing recovery 3,4.
                                                                  metric findings before and after surgery and possible com-
Stapedoplasty is a surgical procedure that can be carried
                                                                  plications were evaluated.
out under either local (LA) or general anaesthesia (GA).
                                                                  When LA was performed, an intravenous sedative such as
Over time, it has been seen that the two types of anaesthesia
                                                                  propofol was administered in a single dose with a peak ef-
have contrasting advantages and disadvantages, playing an
                                                                  fect in the first two minutes in order to avoid that the patient
important role in post-operative hearing outcomes.
                                                                  felt pain during local infiltrations. A mixture of lidocaine
Historically, stapes surgery was performed under LA,
                                                                  2% and mepivacaine 2% was used to infiltrate the auditory
which is advantageous because it allows for communica-
                                                                  external canal in six different points (two in the retroau-
tion with the patient about intraoperative hearing changes,
                                                                  ricular sulcus and four around the external auditory meatus,
vertigo and other symptoms. Conversely, nowadays, GA is
preferred. Benefits of GA include patient comfort in terms        at 12-3-6-9 o’clock); optocaine was then used to inject di-
of anxiety, pain, noise annoyance and vertigo and increased       rectly the postero-superior scutum area.
surgeon’s safety. Moreover, modern GA techniques can              Balanced GA was generally the elective technique for GA:
avoid intubation and the use of heavy drugs, thus being less      the intravenous analgesic drug (remifentanil) was associated
traumatic and allowing a more gradual awakening, result-          with an inhaler anaesthetic (selfuran). Alternatively, total
ing in an less invasive procedure overall 5,6.                    intravenous anaesthesia was performed with a mixture of
In the absence of contraindications for GA or LA, the se-         propofol and remifentanil. During the intervention, cardio-
lection of the anaesthesia method should be based upon            vascular monitoring was ensured together with constant eval-
best hearing outcome evidence.                                    uation of normocapnia. When administering GA, in order to
Remarkably, only a handful of studies have compared out-          have a bloodless operating field, the controlled hypotension
comes based on the type of anaesthesia, and report conflict-      technique was adopted, keeping the average blood pressure
ing and non-definitive results.                                   at values around 60 mmHg. When surgery was performed
On the other hand, the limited literature does not consider the   under GA, the airways were secured with a tracheal tube or
preference of the patient about the type of anaesthesia and fi-   with a supraglottic airways device (SAD). Irrespective of the
nal satisfaction regarding the anaesthetic procedure received.    device, it is important to have strict control of the airways,
The aim of our work is to contribute in establishing wheth-       because there is a limited access to the patient’s head during
er LA or GA performed with the most modern anaesthe-              surgery and the head is not maintained in a neutral position
siological techniques can influence hearing outcome af-           but rather turned to the left or right. Controlled ventilation is
ter primary stape’s surgery. Furthermore, considering the         necessary to avoid respiratory depression and hypercapnia,
anaesthesiological experience and auditory outcomes, we           and therefore bleeding in the surgical field 6,8,9.
discuss how to better match a patient’s wishes and/or needs       In our experience, since we have always used a SAD, we
of the physician’s team with the final acceptance of the ana-     avoided neuromuscular blocking agents. Other advantages
ethesia by the patient and the best functional results.           of SAD also include a smooth emergence from anaesthesia
                                                                  with less chance of coughing and a subsequent increase of
                                                                  ear pressure or bleeding. A standard prophylaxis of post-
Materials and methods                                             operative nausea and vomiting was usually carried out as-
A retrospective study was performed on 55 patients suffer-        sociating ondansetron and dexamethasone, irrespective of
ing from documented otosclerosis and undergoing stape-            the type of anaesthesia.



472
                                                                                  Outcomes in stapes surgery: local vs general anaesthesia




Before the operation (within 3 months) and 1 month after         about the degree of concern about the type of anaesthesia,
surgery, each patient underwent pure tone audiometry (PTA)       using a scale with values from 1 to 5, where such scores
testing including detection of air-conduction (AC) and bone-     correspond to the minimum and the maximum degree of
conduction (BC) thresholds values at frequencies of 250,         concern, respectively.
500, 1000, 2000 and 4000 Hz. AC and BC PTA scores in             After surgery, at the time of discharge and before postoper-
dB HL, before and after surgery, were calculated as follows:     ative audiometric evaluation, LA patients were asked about
• AC PTA = (250 KHz) + (500 Hz) + (1000 Hz) + (2000              pain during local anaesthetic injections and to grade it on a
   Hz) + (4000 Hz)/5;                                            visual scale with values from 1 (no pain) to 10 (very severe
• BC PTA = (250 Hz) + (500 Hz) + (1000 Hz) + (2000 Hz)           pain); in addition, patients were asked if they felt pain even
   + (4000 Hz)/5.                                                during the remainder of the operation and on what occasion
Air Bone Gap (ABG) values, in dB HL before and after             and intensity. At the end of the questionnaire, the presence
surgery, were calculated for each frequency and then the         of nausea or vomiting in the postoperative period was also
mean ABG (µABG) in dB HL before and after stapedo-               checked in both groups of patients. Based on personal ex-
plasty was obtained as follows:                                  perience with stapes surgery, patients were also asked to
- µABG= [(AC 250 Hz - BC 250 Hz) + (AC 500 Hz - BC               grade their overall satisfaction regarding the anaesthesio-
500 Hz) + (AC 1000 Hz - BC 1000 Hz) + (AC 2000 Hz -              logical method, scoring it from 1 (poor satisfaction) to 10
BC 2000 Hz) + (AC 4000 Hz - BC 4000 Hz)]/5                       (high satisfaction).
Before surgery’s ABG score was subtracted from after             Shapiro-Wilk’s test was used to check for normality of
surgery’s ABG value, the obtained value representing the         data. We used unpaired two-tailed Student’s t-test and Chi-
ABG Closure (∆ABG) after stapedoplasty.                          Squared test to compare continuous and discrete variables,
Results were reported according to AAO-HNS Level 1               respectively, in the two groups (GA and LA). Comparison
Guidelines 10:                                                   between pre and post surgery parameters was performed
1. dB HL of ABG after surgery;                                   using a paired sample t test. P-values < than 0.05 were re-
2. dB HL of ∆ABG (ABG Closure);                                  garded as statistically significant. All statistical analyses
3. Change in the average postoperative threshold (of mini-       were performed using Microsoft Excel 2013, SPSS for
   mum audibility) of the bone pathway, expressed as dB          Apple iOS (v. 23, SPSS Inc., Armonk, NY) and the open
   HL lost (∆PTA < -5 dB), recovered (∆PTA > +5 dB) or           source statistical package R, version 3.4.3 (The R Founda-
   unchanged (-5 dB < ∆PTA < 5 dB).                              tion for Statistical Computing, www.r-project.org).
All patients were dismissed on the first post-operative day
after having verified the absence of general, audiological
                                                                 Results
and vestibular complications. All returned to visit on the
third or fourth postoperative day to extract the swab from       The mean age of patients was 53.87 ± 9.59 years and a
the ear canal and to perform the first audiometric testing to    range of 34-73 years. The female to male ratio was 1.5:1
rule out early serious hearing complications. During this        (33 females, 60%, and 22 males, 40%). Thirty-two patients
same visit, the presence of vestibular complications was         (58.2%) underwent GA (17 females, 53.1%, and 15 males,
also investigated by bedside vestibular examination.             46.9%) and 23 (41.8%) were submitted to LA (16 females,
All patients were given some rules of conduct to be main-        69.6%, and 7 males, 30.4%).
tained during the 15 days following the intervention, which      No patient had any notable cardiovascular or respiratory
consisted essentially in avoiding intense physical exertion      risk factors in their clinical history or reported a significant
and large variations in external or internal ear pressure.       drug allergy. None in the sample had to be subjected to an-
In any case, hearing testing was compared with preopera-         tithrombotic prophylaxis before the operation, while in all
tive values performed one month after the operation.             cases a “one shot” antibiotic therapy was administered with
On admission, a satisfaction questionnaire, in use in our        amoxicillin/clavulanate 2 g intravenously immediately be-
hospital and clinically validated for ophthalmological sur-      fore surgery. In no case did anaesthetic complications occur
gery, concerning the global experience with the anaesthetic      during the operation for patients in either group.
technique used, was given to all patients. Before undergo-       In no case, during stapedoplasty, were there serious oto-
ing stapedoplasty, both GA and LA patients were asked            logic complications (i.e. gusher, trauma on the ossicular
to fill in the part of the questionnaire relating to the final   chain, suffering of the facial nerve or inner ear). No patient
choice about the anaesthesiological procedure, namely if it      showed severe hearing (profound hearing loss or anacusis)
was made on their explicit request or upon the advice of the     or vestibular (acute vestibulopathy) consequences after sur-
surgeon or the anaesthetist. The questionnaire also inquired     gery.



                                                                                                                                    473
B. Giannoni et al.




Table I. AC single frequency absolutes values and AC PTA scores before and after stapedoplasty. 13,2020 (original approval: Oct 15, 2014).
 Frequency                  AC threshold before      AC threshold after        P-value      BC threshold before       BC threshold after            P-value
                                  (µ ± SD)                (µ ± SD)                                 (µ ± SD)                 (µ ± SD)
 250 Hz                              56.9 ± 14.73               30.6 ± 10.86            < 0.001*     13.82 ± 5.52            13.98 ± 4.83            0.860
 500 Hz                              59.7 ± 14.15               33.2 ± 12.25            < 0.001*      19.1 ± 8.28             17.2 ± 6.15            0.040*
 1000 Hz                             56.8 ± 14.47               32.8 ± 10.35            < 0.001*      22.3 ± 8.32            20.45 ± 7.01            0.020*
 2000 Hz                             54.2 ± 14.65               35.8 ± 13.01            < 0.001*     33.54 ± 11.21            30 ± 11.05             0.010*
 4000 Hz                             54.9 ± 22.29               47.3 ± 19.07             0.010*      28.54 ± 14.19           34.9 ± 13.82           < 0.001*
 8000 Hz                             57.8 ± 21.49               57.4 ± 22.08             0.870             -                       -                    -
 PTA                                 57.1 ± 13.59               39.5 ± 11.49            < 0.001*     23.45 ± 7.28             23.3 ± 6.49            0.854
BC single frequency absolute values and BC PTA scores before and after stapedoplasty.
µ: means; SD: standard deviation; *: statistically significant data.



In no case did the surgical diagnosis differ from the clinical                          the worsening was slightly significant only for the 4000 Hz
diagnosis of otosclerosis established preoperatively.                                   frequency (Tab. I).
After surgery, the AC minimal auditory threshold absolute                               Regression curves for pre- and postoperative BC PTA val-
values were improved for all frequencies for all patients in                            ues are represented in Figure 2.
both groups under examination. Such an improvement was                                  The results of ABG after surgery (range 2.4-46 dB) were di-
statistically significant (p < 0.05) at all frequencies except                          vided in three groups (bands): 0-10 dB HL (first band), 11-
for 8 KHz. In all subjects, the post-operative AC PTA score                             20 dB HL (second band) and > 20 dB HL (third band) (Fig. 3).
was also significantly improved, changing from mean pre-                                Regarding the GA group, 13 patients (40.6%) belonged to the
operative values of 57.1 ± 13.59 dB to mean postoperative                               first band, 15 (46.9%) to the second band and 4 (12.5%) to the
values of 39.5 ± 11.49 dB (mean PTA improvement of 17.6                                 third. Among LA patients, 9 (39.1%) fit in the first band, 10
dB) (Tab. I).                                                                           (43.5%) in the second one and 4 (17.4%) in the third (Tab. II).
Regression curves for pre- and post-operative AC PTA val-                               Taken together, post-surgical ABG values were not signifi-
ues are reported in Figure 1.                                                           cantly different between patients undergoing GA or LA.
In all patients in both groups, BC minimal auditory thresh-                             In the entire series, mean ABG was 32.9 dB HL before and
old absolute values were also improved after surgery for                                13.0 dB HL after surgery. The difference of ABG before
all frequencies except 250 and 4000 Hz. Actually, such a                                and after stapedoplasty was significant for both groups
gain was significant only for 500, 1000 and 2000 Hz, while                              (p < 0.001) (Fig. 4).




Figure 1. AC PTA values in dB, before (abscissae) and after surgery (ordinates). Density of values is greater under the bisector on the right: higher values were
registered for pre-operative PTA. The inclination of the regression line highlights the relationship between the two parameters.



474
                                                                                                         Outcomes in stapes surgery: local vs general anaesthesia




Figure 2. BC PTA values in dB, before (abscissae) and after surgery (ordinates). The concentrated values on the bisector report a weak variation after surgery.




                  Abscissae: ABG bands; ordinates: patient number.

Figure 3. ABG value distribution after surgery in the GA and LA groups.


Table II. After surgery ABG.
 ABG after surgery           GA (n = 32)            LA (n = 23)      P-value
 0-10 dB                         13 (40.6%)          9 (39.1%)       0.261
                                                                                  Figure 4. ABG before and after surgery in dB.
 11-20 dB                        15 (46.9%)          10 (43.5%)
 > 20 dB                          4 (12.5%)           4 (17.4%)
ABG: air bone gap; GA: general anaesthesia; LA: local anaesthesia.

                                                                                  Table III. ∆ABG (ABG Closure) in dB stratified for bands and anaesthesia
∆ABG (ABG Closure) results were divided in bands, as                              groups.
for ABG values, and compared between LA and GA. We                                 Post-surgical ABG        Mean GA             Mean LA        P-value
found no significant difference between the two anaesthe-                                                     ∆ABG               ∆ABG
sia groups or the three bands (Tab. III).                                          0-10 dB                          24.37 dB            25.55 dB       0.800
After surgery, BC hearing threshold was the third param-                           11-20 dB                         19.54 dB            19.79 dB       0.950
eter evaluated. By subtracting BC PTA after surgery to BC                          > 20 dB                           7.5 dB               7 dB         0.960
PTA before surgery, we obtained BC ∆PTA. A worsening                               Tot dB                            20.3 dB            19.82 dB       0.890
BC hearing threshold was found in 16% of the entire series,                       ABG: air bone gap; GA: general anaesthesia; LA: local anaesthesia.




                                                                                                                                                           475
B. Giannoni et al.




Table IV. BC ∆PTA after surgery; + ≥ 5 dB = improved by a value greater              1 case, dizziness in 1 patient and worry for noise of the drill
than or equal to 5 dB; - ≥ 5 dB = worsened by a value greater than or equal to       in the another 3 cases). In the post-operative period, only
5 dB: -5 dB < x > +5 dB: substantially unchanged (because changed in nega-
tive or positive by a value lower than 5 dB).                                        4/23 patients (17.4%) experienced nausea or vomiting.
  BC ∆PTA                            n.       PTA (µ ± SD)        P-value            The final satisfaction score for LA was 10 in 8/23 patients
                                                                                     (34.8%), 9 in 7/23 (30.4%), 8 in 7/23 (30.4%) and 5 in 1/23
 + ≥ 5 dB            GA         8 (25%)           7.5 ± 1.69
                     LA         3 (13%)          7.67 ± 1.53          0.880          (4.4%), with a mean value of 8.9 points. The comparison
 - ≥ 5 dB            GA        5 (15.6%)        -10.25 ± 3.86                        between the two groups is reported in Table V.
                     LA        4 (17.4%)         -9.25 ± 2.87         0.690          Three of 55 patients complained of dysgeusia after the op-
 ± < 5 dB            GA        19 (59.4%)        -0.53 ± 3.22                        eration: one subject, for which during surgery under GA
                     LA        16 (69.6%)         0.85 ± 3.05         0.200          it was necessary to sacrifice the chorda tympani, had this
BC: bone conduction; GA: general anaesthesia; LA: local anaesthesia; µ: means; SD:   complaint for about one year; the remaining two (one in
standard deviation.
                                                                                     the GA and one in the LA group) complained of this symp-
                                                                                     tom only for a brief period of time because the nerve was
regardless of the type of anaesthesia. BC hearing threshold                          preserved.
was ameliorated by more than 5 dB in 20% and unchanged                               None of the patients had prolonged vestibular symptoms af-
in the remaining 63.6% of patients. BC ∆PTA values were                              ter surgery. Upon discharge, 5 patients complained of slight
not significantly different between GA and LA (Tab. IV).                             dizziness, although bedside vestibular testing were normal.
When compared to subjects undergoing LA, patients sub-                               One patient, suffering from positional vertigo when lying
jected to GA with BC ∆PTA included in the interval +/-5                              and turning in bed towards the operated side, had signs sug-
dB showed a slightly greater hearing loss on the frequency                           gestive of benign paroxysmal positional vertigo. This was
                                                                                     resolved by physical therapy and the patient was symptom-
of 4000 Hz (p = 0.018, µGA = -3.12 dB, µLA = -0.33 dB).
                                                                                     free at the first control. Among the 6 patients, 3 underwent
In 14 patients (25.4%), we observed a sensorineural hear-
                                                                                     GA and 3 LA.
ing loss > 15 dB at 4000 Hz.
Regarding the results of the questionnaire in the group of
patients operated on under GA, the final decision on the                             Discussion
type of anaesthesia was made in 17 of 32 cases (53.1%) at                            The literature that takes into consideration the problem we
the explicit request of the patient, in 14 cases (43.8%) after                       have faced is scarce and inhomogeneous for the population
the surgeon’s advice and in 1 case (3.1%) on the advice of                           examined, the objective of the study and the results. In a
the anaesthetist. The patients’ VAS level of concern about                           review of 257 papers comparing hearing outcomes between
GA was 1 point in 16/32 subjects (50%), 2 points in 6/32                             stape’s surgery performed under GA and LA, Wegner
(18.8%), 3 points in 5/32 (15.6%), 4 points in 2/32 (6.2%)                           found only 3 surveys satisfying eligibility criteria 11. It was
and 5 points in 3/32 (9.4%), with a mean value of 2.06.                              concluded that there was no difference between the two
After surgery, only 3 of 32 patients (9.4%) reported nausea                          anaesthesiological types in post-operative ABG or in post
or vomiting. Overall, the satisfaction score for GA was 10                           surgery BC hearing threshold, or post-operative vertigo.
for 15/32 patients (46.9%), 9 for 10/32 patients (31.3%), 8                          However, in one of these 3 studies, Vital found complete
in 3/32 cases (9.4%), 7 in 2/32 cases (6.2%) and 6 for the                           hearing loss only among those submitted to GA (3/160 pa-
remaining 2 (6.2%). The mean acceptance score for GA                                 tients, 1.87%) 12. In another study, Mathews observed that
was 9.1 and no patient reported satisfaction values below 6.                         GA allowed better and safer learning for residents 13. Ba-
Among patients undergoing LA, the decision regarding the                             bighian 14 reviewed 78 revision stapes operations to deter-
type of anaesthesia was made by the patient in 11/23 cases                           mine the causes of failure of the first intervention. For such
(47.8%), after the surgeon’s advice in 8/23 (34.8%) and fol-                         surgery, hearing outcomes were comparable between the
lowing the interview with the anaesthetist in 4/23 (17.4%).                          two types of anaesthesia. In any case, the author argued that
The VAS level of concern for LA was 1 in 19/23 patients                              LA should be preferred because it allows better monitoring
(82.6%) and 2 in 4/23 (17.4%), with a mean value of 1.17.                            of the labyrinthine function.
During periauricular injections of local anaesthetic, only 4                         In Wegner’s review, only 2 papers reported the description
(17.4%) of 23 patients reported pain. The pain level de-                             of the anaesthesiological technique. In particular, Mathews
scribed by these 4 patients on the VAS scale was 3, 4, 7                             used a mix of 1% or 2% lidocaine with 1:100,000 epi-
and 8 (mean value 5.5). During the surgical procedure, 2/23                          nephrine augmented by intravenous analgesia and sedation
subjects (8.7%) reported a pain score of 7 and 8 respective-                         for LA and endotracheal intubation with inhaled and in-
ly, and 5/23 (21.7%) referred to discomfort (feeling cold in                         travenous narcotic agents for GA 13. Vital described only



476
                                                                                              Outcomes in stapes surgery: local vs general anaesthesia




Table V. Comparison of questionnaire responses between GA and LA patients.
                                                                                        Local (n = 23)      General (n = 32)          P-value
Who most influenced the choice of the type of anaesthesia?
  The surgeon                                                                            8 (34.8%)             14 (43.8%)              0.188
  The anaesthetist                                                                       4 (17.4%)              1 (3.1%)
  The patient                                                                            11 (47.8%)            17 (53.1%)
How worried was the patient about having to undergo anaesthesia?
  1                                                                                      19 (82.6%)            16 (50%)
  2                                                                                       4 (17.4%)            6 (18.8%)
  3                                                                                           0                5 (15.6%)               0.051
  4                                                                                           0                 2 (6.2%)
  5                                                                                           0                 3 (9.4%)               0.001*
  Mean                                                                                   1.17 ± 0.39          2.06 ± 1.34
Did you experience pain/discomfort during injection of the local anaesthetic?
  Yes                                                                                     4 (17.4%)                 -
  No                                                                                     19 (82.6%)                 -                     -
Did you experience pain/discomfort during the surgery?
  Pain                                                                                    2 (8.7%)                  -
  Discomfort                                                                              5 (21.7%)                 -
  No                                                                                     16 (69.6%)                 -                     -
Did you have postoperative nausea/vomiting?
  Yes                                                                                     4 (17.4%)             3 (9.4%)               0.379
  No                                                                                     19 (82.6%)            29 (90.6%)
Overall, how satisfied were you?
  1                                                                                            0                    0
  2                                                                                            0                    0
  3                                                                                            0                    0                  0.156
  4                                                                                            0                    0
  5                                                                                        1 (4.4%)                 0
  6                                                                                            0                2 (6.2%)
  7                                                                                            0                2 (6.2%)
  8                                                                                       7 (30.4%)             3 (9.4%)
  9                                                                                       7 (30.4%)            10 (31.3%)
  10                                                                                      8 (34.8%)            15 (46.9%)              0.554
  Mean                                                                                    8.9 ± 1.2             9.1 ± 1.2


the method used for LA, which was injection of the ex-                       The absolute AC minimal auditory threshold as well as pre
ternal auditory canal with 1% lidocaine with epinephrine                     and postoperative AC PTA values significantly improved
1:100,000 at the bony-cartilaginous junction of the four                     after surgery in both anaesthesiological groups.
quadrants 12. Finally, Loewenthal considered 88 stapedoto-                   Similarly, by comparing the overall pre and post surgical
mies and compared hearing outcomes obtained when per-                        BC scores between groups, it can be observed that in most
forming surgery under GA and LA and by using microdrill                      cases (83.6%) there was improvement or stability. The only
and laser techniques for footplate perforation. Outcomes                     frequency at which a greater worsening was noted, only
were equally satisfying for both surgical and anaesthetic                    for GA, was 4000 Hz. On the other hand, this difference is
procedures. However, barely superior outcomes were seen                      only weakly significant and would need to be confirmed in
for GA in combination with conventional microdrill 8.                        a larger sample.
Our cohort is homogeneous for sex and age both absolutely                    The postoperative ABG value was also very restrained
and with respect to the two groups of anaesthesia. Moreo-                    (< 20 dB) regardless of the type of anaesthesia chosen. In
ver, the sample is in line with what reported in the literature              reality, mean ABG after surgery was 13 dB HL, a value
about the demographic characteristics of otosclerosis at the                 that is very close to that of 10 dB HL, the best value recom-
age suitable for stapedoplasty.                                              mended in the literature as the desirable outcome following
Otosclerosis was the only confirmed diagnosis, also sur-                     stapes surgery 10.
gically. Hearing outcomes after stapes surgery have been                     Also considering the ABG recovery bands, it can be seen
globally successful for all patients neither a significant de-               not only that most of patients belonged to the better recov-
terioration of hearing nor anacusis.                                         ery bands (therefore with smaller ABG and greater ∆ABG),



                                                                                                                                                477
B. Giannoni et al.




but also that the percentages were equally distributed in the    there is a limited access to the patient’s head since it is al-
two anaesthetic groups.                                          ways turned sideways. Obviously, GA ensures patient’s im-
From an otosurgical point of view, conducting stapedoplas-       mobility and is comfortable for patients with anxiety, pain
ty under LA, and thus having the patient conscious, has the      and noise discomfort. Due to the these aspects, unlike LA,
undoubted advantage of being able to test the patient’s sub-     GA is also more suitable for residents to acquire practical
jective hearing after the insertion of the prosthesis. At that   skills.
time, an awake patient should also report the appearance of      Until recently, one of the most significant disadvantages
vertigo as an expression of a labyrinthine mechanical insult     of GA has been to require invasive ventilation manoeu-
that can be attributed to an excessive length of the piston      vers and heavy drugs. Nevertheless, the most modern oto-
or to its malpositioning. The lack of subjective hearing re-     surgical GA techniques involve the insertion of a SAD in
covery, even partial, or the occurrence of vestibular events,    place of an endotracheal device, also avoiding the risk of
may allow the surgeon to check the fit of the prosthesis in      injury to surrounding tissues. Using SAD, it is possible
order to avoid disturbances or lesions. LA is a non-invasive     to not use muscle relaxants and to employ lower amounts
procedure whose effect is quickly disposed after surgery         of anaesthetic drugs: this considerably shortens the awak-
and in which the drugs used do not usually cause side ef-        ening phase after the operation, making it smoother with
fects. Moreover, LA does not have the risk of provoking          less chances of coughing and thus the occurrence of early
mechanical trauma on the aero-digestive tracts that are ca-      otologic complications (bleeding, vertigo, hearing loss,
pable of provoking voice or swallowing disorders. The use        prosthesis dislocation). Secondly, during GA the patient
of loco-regional anaesthetic drugs allows the application of     is unconscious and, therefore, it is not possible to check
this type of anaesthesia even in subjects with significant       subjective hearing performance at the end of the surgical
cardio-circulatory comorbidities and in polytherapy.             procedure.
On the other hand, LA has some limitations especially            In our experience, neither of the two anaesthesiological
related to the difficulty for the patient in maintaining the     techniques had ever given rise to serious medical compli-
same position for a long time and in avoiding sudden move-       cations, either during or after surgery.
ments that could be dangerous for the delicate surgical ma-      In most cases in our series, the choice of the type of anaes-
noeuvers. In addition, LA necessitates a cooperative and         thesia was left as a free choice to the patient, since for these
relaxed patient and it is thus not recommended for anxious       subjects there were no clinical reasons to indicate one over
people or for those who have neurological, pneumological         the other. This was the reason why these patients started
or orthopaedic disorders that can limit their compliance to      from an initial condition of serenity and availability. Only
maintain a forced position. The limited duration of the ef-      for a small number of patients was the decision made by
fects of the local anaesthetics, however sometimes does not      the anaesthetist and/or by the surgeon because of clinical
allow the complete covering of a possible extension of the       contraindications to GA or due to anatomo-functional or
surgical times in case of complications.                         psychological conditions.
The main advantage of general anaesthesia is to allow con-       The majority of patients in both groups underwent the cho-
trolled management of blood pressure values to limit bleed-      sen anaesthesia with a minimum level of concern, further
ing in the operating field. In fact, during otosurgery, and      confirming the importance of the patient’s independent
especially in stapedoplasty, it is essential to have a clean     choice and/or the relationship of trust that must be created
and bloodless operating field to clearly see landmarks and       between the surgeon and the patient in view of the opera-
small middle ear structures, and to avoid aspirating the         tion.
perilymph from the stapedotomy along with blood. Con-            Nausea and/or vomiting were infrequent post-operative
trolled hypotension is achieved by inhalation anaesthetics       events in both GA and LA patients. This confirms the op-
such as isoflurane and sevoflurane. When used in moder-          portunity to use antiemetic drugs to control autonomic
ate concentrations the latter drugs can have a vasodilating      symptoms due to platinotomy and prosthesis insertion.
effect thus turning down blood pressure levels and result-       Only a small fraction of LA patients reported pain during
ing in a neuroprotective effect. The hypotensive effect of       local anaesthetic injections and/or during the entire surgi-
sevoflurane does not act on cochlear blood flow. At higher       cal procedure. This important result is achieved thanks to
concentrations, these anaesthetic agents have a vasodilator      the effectiveness of sedation and pain relief therapy which
effect that can increase cerebral flow and worsen cerebral       is always used in this type of anaesthesia. This aspect is of
autoregulation 6,15,16.                                          fundamental importance in the outcomes of stapedoplasty,
Controlling the airways, by means of an endotracheal tube        since the lowest possible perception of pain allows the pa-
or of a SAD, may be important because during ear surgery         tient to remain immobile during the procedure and there-



478
                                                                                   Outcomes in stapes surgery: local vs general anaesthesia




fore not to invalidate the intervention with sudden move-          the type of anaesthesia received, no differences emerged
ments related to painful symptoms.                                 between the two techniques. It can be observed that the
In the few cases of discomfort recorded, the most frequent         choice of the type of anaesthesia, pre-eminently performed
was nuisance to the noise of the drill. However, this never        by the patient, can introduce a bias in subsequent judgment
led the patient to make rash movements.                            of the satisfaction of the anaesthesia itself. In reality, in
All patients completed the satisfaction questionnaire on the       some cases the choice was also made by the audiologist or
day of discharge even before undergoing the first medica-          the anaesthetist, and therefore not entirely free from bias.
tion and the first audiogram, on the third-fourth day after        However, it might be interesting in the future to improve
surgery. We chose to deliver the questionnaire at that time        the weight of our conclusions by carrying out double-blind
to prevent the quality of functional results from influencing      studies and matching patients randomly divided by anaes-
the patient’s responses. Patients in both groups reported a        thetic group.
high degree of satisfaction regarding the anaesthetic treat-       Therefore, the choice of the type of anaesthesia can ob-
ment. Once the quantitative results were obtained, the bet-        jectively continue to be guided on the basis of medical
ter the recovery, the greater the patient’s satisfaction ex-       or surgical needs or the patient preference. Nevertheless,
pressed in the questionnaire.                                      working in a university clinical facility and as the modern
The latter aspects can be interpreted in the sense that a calm     techniques of GA are now at low risk and very comfortable
and grateful attitude toward the assistance of the physi-          for the patient, one can lean towards the latter anaesthesio-
cians’ team can also positively influence both qualitative         logical technique in order to facilitate the training of physi-
and quantitative functional recovery after stapedoplasty.          cians in specialist training and expand the surgical experi-
Patients who underwent GA reported a significantly greater         ence of specialists.
degree of concern than those who knew they should only
receive LA.                                                        Conflict of interest statement
Therefore, the overall hearing outcomes that we found in           The authors declare no conflict of interest.
our cohort are superimposable whether the patient under-
goes stapedoplasty in GA or in LA, and therefore there is          Funding
not the need to choose one or the other method for strictly        This research did not receive any specific grant from fund-
audiological reasons.                                              ing agencies in the public, commercial, or not-for-profit
Considering the strengths and weaknesses of one or the             sectors.
other anaesthesiologic technique, we observed that these
are equivalent and that even a technique considered inva-          Author contributions
sive until some time ago cannot be considered as such at           BG: conceived, designed and wrote the study, elaborated
present, thanks to the airway control devices that makes the       data and interpreted their meaning. FP: designed and wrote
procedure only mildly traumatic, and to the use of drugs           the study, contributed to data collection and clinical inter-
that are short-lasting.                                            pretation. CA: contributed to work’s conception and design,
Finally, patient satisfaction with one or the other type of        performed and supervised anaestethic procedures, contrib-
anaesthesia was the same even if, initially, patients who had      uted to data collection. DS: contributed to data collection
to undergo GA were a somewhat more worried.                        and elaboration. PV: performed operations and contributed
                                                                   to data collection. AS: contributed to data collection and
                                                                   elaboration. CC: performed statistical analysis, contributed
Conclusions                                                        to data elaboration. CB: contributed to statistical analysis,
Stapedoplasty is a safe surgical procedure with consider-          data elaboration and clinical interpretation. RP: conceived
able benefits on auditory function when the correct indica-        the study, contributed to wrote the paper, data collection
tions exist and if it is carried out by highly trained surgeons,   and clinical interpretation.
independently from the type of anaesthesia.
Our study confirms the limited literature observations that        Ethical consideration
hearing results following stapedoplasty do not differ if sur-      This study was approved by the Institutional Review Board
gery is performed in GA or LA. One anaesthetic technique           for Human Subjects Research for AOU Careggi. Subjects
is not to be preferred, even when considering the relative         gave informed consent prior to participation (approval
advantages and limitations. With the present analysis, we          numbe 19751/055).
also wanted to examine the subjective aspects of the pa-           The research was conducted ethically, with all study pro-
tient: evaluation of the degree of satisfaction regarding          cedures being performed in accordance with the require-



                                                                                                                                     479
B. Giannoni et al.




ments of the World Medical Association’s Declaration of                      8
                                                                                  Loewenthal M, Jowett N, Busch CJ, et al. A comparison of hear-
                                                                                  ing results following stapedotomy under local versus general anes-
Helsinki.                                                                         thesia. Eur Arch Otorhinolaryngol 2015;272:2121-2127. https://doi.
                                                                                  org/10.1007/s00405-014-3014-6
References                                                                   9
                                                                                  Pairaudeau C, Mendonca C. Anaesthesia for major middle ear
                                                                                  surgery. BJA Educ 2019;19:136-143. https://doi.org/10.1016/j.
1
    Uppal S, Bajaj Y, Rustom I, et al. Otosclerosis 1: the aetiopathogen-         bjae.2019.01.006
    esis of otosclerosis. Int J Clin Pract 2009;63:1526-1530. https://doi.   10
                                                                                  Committee on Hearing and Equilibrium guidelines for the evaluation
    org/10.1111/j.1742-1241.2009.02045.x                                          of results of treatment of conductive hearing loss. American Academy
2
    Menger DJ, Tange RA. The aetiology of otosclerosis: a review of the           of Otolaryngology-Head and Neck Surgery Foundation, Inc. Otolar-
    literature. Clin Otolaryngol Allied Sci 2003;28:112-120. https://doi.         yngol Head Neck Surg 1995;113:186-187. https://doi.org/10.1016/
    org/10.1046/j.1365-2273.2003.00675.x                                          S0194-5998(95)70103-6
3
    Bittermann AJ, Rovers MM, Tange RA, et al. Primary stapes surgery
                                                                             11
                                                                                  Wegner I, Bittermann AJ, Zinsmeester MM, et al. Local versus gen-
    in patients with otosclerosis: prediction of post-operative outcome.          eral anesthesia in stapes surgery for otosclerosis: a systematic review
                                                                                  of the evidence. Otolaryngol Head Neck Surg 2013;149:360-365.
    Arch Otolaryngol Head Neck Surg 2011;137:780-784. https://doi.
                                                                                  https://doi.org/10.1177/0194599813493393
    org/10.1001/archoto.2011.100
                                                                             12
                                                                                  Vital V, Konstantinidis I, Vital I, et al. Minimizing the dead ear in oto-
4
    Quaranta N, Piccininni K, Romanello M, et al. The impact of intra-            sclerosis surgery. Auris Nasus Larynx 2008;35:475-479. https://doi.
    operative factors in otosclerosis outcomes: retrospective study in a          org/10.1016/j.anl.2007.11.002
    tertiary centre. Acta Otorhinolaryngol Ital 2019;39:197-204. https://    13
                                                                                  Mathews SB, Rasgon BM, Byl FM. Stapes surgery in a residen-
    doi.org/10.14639/0392-100X-2004
                                                                                  cy training program. Laryngoscope 1999;109:52-53. https://doi.
5
    Yung MW. Local anaesthesia in middle ear surgery: survey of patients          org/10.1097/00005537-199901000-00011
    and surgeons. Clin Otolaryngol Allied Sci 1996;21:404-408. https://      14
                                                                                  Babighian GG, Albu S. Failures in stapedotomy for otosclero-
    doi.org/10.1046/j.1365-2273.1996.00814.x                                      sis. Otolaryngol Head Neck Surg 2009;141:395-400. https://doi.
6
    Liang S, Irwin MG. Review of anesthesia for middle ear sur-                   org/10.1016/j.otohns.2009.03.028
    gery. Anesthesiol Clin 2010;28:519-528. https://doi.org/10.1016/j.       15
                                                                                  Degoute CS. Controlled hypotension: a guide to drug choice. Drugs
    anclin.2010.07.009                                                            2007;67:1053-1076. https://doi.org/10.2165/00003495-200767070-00007
7
    Yung MW, Oates J, Vowler SL. The learning curve in stapes surgery        16
                                                                                  Doyle DJ, Goyal A, Garmon EH. American Society of Anesthesiolo-
    and its implication to training. Laryngoscope 2006;116:67-71. https://        gists Classification. 2022 Oct 3. In: StatPearls [Internet]. Treasure Is-
    doi.org/10.1097/01.mlg.0000184509.01049.06                                    land (FL): StatPearls Publishing; 2022.




480
