Tympanoplasty is an established surgical procedure performed to reconstruct tympanic membrane perforations and restore middle-ear function in patients with chronic otitis media. The primary objectives include closure of tympanic membrane defects, prevention of recurrent middle-ear infections, and improvement of conductive hearing impairment. Successful outcomes depend on several factors, including middle-ear pathology, surgical technique, Eustachian tube function, graft material, and appropriate perioperative management. The choice of anaesthetic technique is an important component of surgical planning because it may influence patient comfort, operative conditions, cardiovascular responses, and postoperative recovery. Tympanoplasty can be performed under general anaesthesia or local anaesthesia supplemented by sedation. General anaesthesia provides unconsciousness, immobility, airway control, and controlled operating conditions. These characteristics can be beneficial during prolonged otological procedures requiring microscopic precision. However, general anaesthesia may be associated with airway instrumentation, postoperative nausea and vomiting, sore throat, hemodynamic fluctuations, and recovery-related resource utilization. Local anaesthesia with sedation offers an alternative for appropriately selected and cooperative patients. This approach generally involves infiltration of local anaesthetic agents into the surgical field, combined with monitored intravenous sedation to improve comfort and reduce anxiety. It may permit avoidance of endotracheal intubation and provide opportunities for shorter postoperative recovery. Nevertheless, intraoperative discomfort, patient movement, anxiety, and sedation-related respiratory depression require careful monitoring. A systematic review and meta-analysis by Kaleva et al. compared tympanic membrane repair performed under general and local anaesthesia. Their findings supported the consideration of local anaesthesia as an effective alternative in selected patients, particularly when anatomical surgical outcomes were evaluated [1]. The findings also highlighted the importance of patient selection and recognition of methodological differences between available studies. Satasia et al. compared general anaesthesia with monitored anaesthesia care using dexmedetomidine in patients undergoing tympanoplasty. The investigation included 100 patients allocated to two anaesthetic approaches and evaluated the feasibility of monitored local anaesthesia as an alternative to general anaesthesia [2]. These observations emphasize the importance of comparing clinical outcomes rather than assuming that either approach is universally preferable. The quality of sedation is particularly important during tympanoplasty performed under local anaesthesia. Parikh et al. conducted a prospective randomized double-blind study comparing dexmedetomidine with a combination of midazolam and fentanyl in 90 patients. The investigators reported improved patient and surgeon satisfaction with dexmedetomidine, although reductions in heart rate and blood pressure required attention [3]. These findings demonstrate that sedation choice may influence perioperative experience and cardiovascular stability. Previous investigations have also examined the feasibility of middle-ear procedures performed under local anaesthesia and sedation. Yung demonstrated that such operations could be undertaken with acceptable surgical conditions and minor complications in appropriately selected patients [4]. In addition, research evaluating conscious sedation during tympanoplasty has shown that both propofol-based and midazolam-based regimens may provide satisfactory intraoperative conditions [5]. Despite these findings, differences in surgical populations, anaesthetic regimens, perioperative protocols, and outcome definitions limit direct comparisons across studies. Functional recovery, intraoperative comfort, postoperative nausea and vomiting, and patient satisfaction may be as important as conventional anatomical success measures when selecting an anaesthetic approach.

The proposed investigation will be a prospective, randomized, parallel-group controlled clinical study conducted jointly by the Departments of Anaesthesiology and Oto-Rhino-Laryngology, Mamata Medical College, Khammam, Telangana, India. Recruitment will begin only after approval from the Institutional Ethics Committee and prospective clinical trial registration. The study period will be specified in the finalized protocol. 2.2 Study population Adult patients aged 18–60 years undergoing elective primary type I tympanoplasty for inactive mucosal chronic otitis media will be screened for eligibility. Patients must be suitable for either general anaesthesia or local anaesthesia with sedation and capable of providing informed consent. Inclusion criteria: ASA physical status I or II; elective primary type I tympanoplasty; intact ossicular chain; ability to cooperate with surgery under monitored sedation; and consent to randomization. Exclusion criteria: Anticipated difficult airway requiring a specific airway strategy, contraindications to the proposed anaesthetic medications, inability to cooperate during awake surgery, significant uncontrolled systemic illness, known allergy to study medications, pregnancy, and procedures requiring additional ossicular or mastoid reconstruction. 2.3 Sample size and randomization The sample size will be determined before enrolment according to a prespecified primary outcome. For this study, the primary outcome will be postoperative recovery time, defined as the interval from completion of surgery to attainment of a predetermined modified Aldrete recovery score. A calculation for comparison of two independent means will be performed using an expected difference and standard deviation from previous studies, 80% or greater statistical power, and a two-sided significance level of 0.05. An allowance will be made for withdrawal and incomplete follow-up. Participants will be assigned to either group in a 1:1 ratio using computer-generated randomization and concealed allocation. Although participants and anaesthesiologists cannot be reliably blinded to the anaesthetic technique, postoperative outcome assessors and statisticians will be blinded where feasible. 2.4 Anaesthetic techniques Group GA — General anaesthesia: Patients will receive a standardized general anaesthesia protocol involving intravenous induction, appropriate airway management, and maintenance using approved anaesthetic agents. Analgesics, muscle relaxants, antiemetics, and intravenous fluids will be administered according to the predefined clinical protocol. Group LA — Local anaesthesia with sedation: Patients will receive local infiltration anaesthesia administered by the operating surgeon, combined with monitored intravenous sedation. A predefined sedation regimen will be used and titrated to a clinically appropriate sedation target. Standard monitoring will include electrocardiography, noninvasive blood pressure, pulse oximetry, and capnography when indicated. Both groups will receive equivalent surgical care, including standardized graft selection principles, surgical technique, and postoperative instructions. Inadequate anaesthesia, significant patient discomfort, or airway compromise will prompt immediate rescue treatment, including conversion to general anaesthesia when clinically necessary. 2.5 Intraoperative monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at baseline and at regular intraoperative intervals. Hypotension, bradycardia, hypoxemia, airway intervention, unplanned movement, and rescue medication requirements will be documented using predefined criteria. Surgical field quality will be assessed by the operating surgeon using a standardized rating scale. Duration of surgery and anaesthesia will be recorded separately. 2.6 Postoperative assessment Recovery time will be measured using the same predefined discharge-readiness criteria in both groups. Postoperative pain will be assessed using a 0–10 numerical rating scale at standardized intervals. The incidence of postoperative nausea, vomiting, dizziness, and other complications will be documented during the first 24 hours. Patient satisfaction and surgeon satisfaction will be assessed using standardized numerical scales. Participants requiring conversion from local to general anaesthesia will remain in their originally assigned group for the primary intention-to-treat analysis. Tympanic membrane graft integrity and pure-tone audiometric outcomes will be evaluated at approximately three months, with later follow-up where feasible. 2.7 Statistical analysis Continuous variables will be expressed as mean ± standard deviation or median with interquartile range. Categorical variables will be expressed as frequencies and percentages. The primary outcome will be compared using an independent-samples t-test or an appropriate nonparametric alternative. Repeated hemodynamic observations will be analysed using mixed-effects models. Categorical outcomes will be assessed using chi-square or Fisher's exact tests. Between-group effect estimates and 95% confidence intervals will be reported. A two-sided p-value below 0.05 will indicate statistical significance for the prespecified primary comparison.

The results tables below are prepared for the proposed clinical study. No institutional outcome values have been assumed. Table 1. Demographic and baseline clinical characteristics Variable General anaesthesia Local anaesthesia with sedation Total patients, n Pending Pending Age, mean ± SD Pending Pending Male, n (%) Pending Pending Female, n (%) Pending Pending Body mass index, mean ± SD Pending Pending ASA I, n (%) Pending Pending ASA II, n (%) Pending Pending Baseline mean arterial pressure Pending Pending This table will describe the baseline characteristics of both groups. Distribution of age, sex, body mass index, and ASA physical status will help assess comparability following randomization. Baseline differences should be considered during interpretation, particularly when evaluating hemodynamic variables. Table 2. Comparison of intraoperative hemodynamic parameters Parameter General anaesthesia Local anaesthesia with sedation p-value Baseline heart rate (beats/min) Pending Pending Pending Mean intraoperative heart rate Pending Pending Pending Baseline MAP (mmHg) Pending Pending Pending Mean intraoperative MAP Pending Pending Pending Maximum MAP reduction (%) Pending Pending Pending Lowest recorded SpO₂ (%) Pending Pending Pending Table 2 will compare cardiovascular and respiratory variables between the anaesthetic groups. Differences may reflect the effects of induction, maintenance agents, sedation, local infiltration, or surgical stimulation. Interpretation will require consideration of rescue medications and other intraoperative factors. Table 3. Intraoperative surgical characteristics Parameter General anaesthesia Local anaesthesia with sedation p-value Duration of surgery (minutes) Pending Pending Pending Duration of anaesthesia (minutes) Pending Pending Pending Estimated blood loss (mL) Pending Pending Pending Surgical field quality score Pending Pending Pending Intraoperative patient movement, n (%) Pending Pending Pending Additional analgesia required, n (%) Pending Pending Pending Conversion to general anaesthesia, n (%) Not applicable Pending — This table will evaluate surgical operating conditions and anaesthetic adequacy. Unplanned movement, additional analgesic administration, and conversion to general anaesthesia are important indicators of the practical limitations of local anaesthesia with sedation. Surgical duration and estimated blood loss will provide additional information about operative efficiency. Table 4. Postoperative recovery characteristics Recovery parameter General anaesthesia Local anaesthesia with sedation p-value Time to recovery readiness (minutes) Pending Pending Pending Pain score at 1 hour Pending Pending Pending Pain score at 6 hours Pending Pending Pending Pain score at 24 hours Pending Pending Pending Rescue analgesia required, n (%) Pending Pending Pending Postoperative nausea, n (%) Pending Pending Pending Postoperative vomiting, n (%) Pending Pending Pending Table 4 will compare early recovery outcomes. Recovery readiness will be evaluated using identical criteria in both groups, making the results more suitable for comparison. Differences in nausea, vomiting, pain, and rescue analgesic requirements may influence patient comfort and postoperative care requirements. Table 5. Patient and surgeon satisfaction Satisfaction outcome General anaesthesia Local anaesthesia with sedation p-value Patient satisfaction score (0–10) Pending Pending Pending Surgeon satisfaction score (0–10) Pending Pending Pending Patients willing to choose the same technique again, n (%) Pending Pending Pending Patients reporting significant intraoperative discomfort, n (%) Not assessed during unconsciousness Pending — This table will assess patient-reported experiences and surgeon satisfaction with each technique. Satisfaction is influenced by multiple factors, including pain, anxiety, nausea, recovery time, and expectations. Intraoperative discomfort cannot be compared directly between unconscious patients and those receiving sedation, so the final analysis should distinguish these different clinical experiences. Table 6. Postoperative graft integrity and audiological outcomes Outcome General anaesthesia Local anaesthesia with sedation p-value Intact tympanic membrane graft at 3 months, n (%) Pending Pending Pending Residual perforation, n (%) Pending Pending Pending Preoperative air–bone gap (dB) Pending Pending Pending Postoperative air–bone gap (dB) Pending Pending Pending Mean air–bone gap improvement (dB) Pending Pending Pending Postoperative complications, n (%) Pending Pending Pending Table 6 will assess whether anatomical and audiological outcomes differ between the groups. Because the reconstructive technique and middle-ear pathology are major determinants of graft and hearing outcomes, these results should be interpreted alongside surgical characteristics. A statistically nonsignificant difference should not automatically be interpreted as proof of equivalent outcomes.

The choice between general anaesthesia and local anaesthesia with sedation for tympanoplasty depends on patient characteristics, surgeon preference, procedural complexity, available resources, and expected perioperative outcomes. Both techniques can provide acceptable conditions for selected otological procedures, although their relative advantages differ. The proposed study is intended to compare these approaches using standardized assessments of hemodynamic responses, recovery, surgical conditions, patient satisfaction, and anatomical outcomes. Kaleva et al. conducted a systematic review and meta-analysis comparing general and local anaesthesia for myringoplasty [1]. Their findings supported the feasibility of tympanic membrane repair under local anaesthesia and did not establish a clear anatomical advantage for general anaesthesia. However, the available evidence included studies with methodological differences, and the results should be interpreted cautiously. The distinction between anatomical closure and broader perioperative outcomes is especially relevant because successful grafting does not necessarily indicate superior patient comfort or recovery. Satasia et al. compared general anaesthesia with monitored anaesthesia care using dexmedetomidine in 100 tympanoplasty patients [2]. Their findings demonstrated the clinical feasibility of a local anaesthesia-based technique and provided evidence that monitored sedation may offer suitable operating conditions in selected patients. Nevertheless, sedation strategies should not be regarded as risk-free because cardiovascular depression and airway-related complications remain possible. Parikh et al. performed a randomized double-blind study involving 90 patients undergoing tympanoplasty under local anaesthesia [3]. Dexmedetomidine was compared with a midazolam–fentanyl regimen. Patient and surgeon satisfaction scores were higher in the dexmedetomidine group, and fewer patients required rescue fentanyl. However, the dexmedetomidine group experienced lower heart rate and mean arterial pressure, with one patient developing bradycardia accompanied by hypotension. These observations emphasize that effective sedation requires careful titration and continuous monitoring. Yung evaluated middle-ear surgery under local anaesthesia and sedation in 73 patients [4]. The procedures were completed without conversion to general anaesthesia, and operative conditions were reported as satisfactory. This study demonstrated the feasibility of local anaesthesia for middle-ear surgery but also indicated the need for comparative investigations. The findings support the importance of assessing patient selection and intraoperative cooperation when designing similar studies. Research comparing conscious sedation regimens during tympanoplasty has provided additional information regarding patient comfort and recovery. Investigators comparing propofol-based and midazolam-based sedation reported acceptable operating conditions with both techniques, although recovery characteristics and postoperative symptoms differed [5]. These findings suggest that the outcomes of local anaesthesia with sedation may depend partly on the sedative agent and analgesic protocol rather than on the local anaesthetic approach alone. Patient discomfort during middle-ear surgery may arise from prolonged head and neck positioning, suction noise, pressure sensations, and anxiety. A prospective study of retroauricular tympanoplasty and tympanomastoidectomy performed under local anaesthesia with sedation demonstrated that procedures were generally well tolerated, although positional discomfort remained an important concern [6]. Adequate preoperative counselling and appropriate sedation may therefore improve the patient experience. General anaesthesia offers the advantage of immobility and controlled airway management, which may be desirable in patients with severe anxiety or when technically complex surgery is anticipated. However, it may also involve recovery-related complications, including nausea and vomiting. Local anaesthesia with sedation may reduce the need for airway instrumentation but requires careful attention to spontaneous ventilation, sedation depth, and patient movement.

Current evidence suggests that local anaesthesia with monitored sedation can be a feasible alternative for selected tympanoplasty procedures. Nevertheless, effective sedation requires careful monitoring because of the potential for cardiovascular and respiratory complications. The proposed study will evaluate postoperative recovery, hemodynamic stability, patient satisfaction, surgical field quality, and tympanoplasty outcomes to support evidence-based anaesthetic selection. Any definitive comparative conclusion will depend on the results obtained from the actual institutional study population.

1. Kaleva AI, Raithatha A, Tomasoni M, Borsetto D, Vijendren A. General anaesthetic vs local anaesthetic myringoplasties: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2023;280(5):2237-2245. doi: 10.1007/s00405-022-07734-8. 2. Satasia J, Vaniya J, Pandya C. Comparison of tympanoplasty under general anaesthesia and monitored anaesthesia care with dexmedetomidine. Natl J Integr Res Med. 2017;8(4). Available from: Journal article. 3. Parikh DA, Kolli SN, Karnik HS, Lele SS, Tendolkar BA. A prospective randomized double-blind study comparing dexmedetomidine vs. combination of midazolam-fentanyl for tympanoplasty surgery under monitored anesthesia care. J Anaesthesiol Clin Pharmacol. 2013;29(2):173-178. doi: 10.4103/0970-9185.111671. 4. Edussuriya B, Goonasekera CD, Rajapakse M, Rajapakse VP, Jayasooriya D. Middle ear surgery under local anaesthesia and sedation. Ceylon Med J. 1997;42(2):75-77. Available from: PubMed. 5. Conscious sedation for middle ear surgeries: a comparison between fentanyl-propofol and fentanyl-midazolam infusion. Saudi J Anaesth. 2015. Available from: PubMed. 6. Sarmento KM de A Jr, Tomita S. Retroauricular tympanoplasty and tympanomastoidectomy under local anesthesia and sedation. Acta Otolaryngol. 2009;129(7):726-728. doi: 10.1080/00016480802398996. 7. Yung MW. Local anaesthesia in middle ear surgery: survey of patients and surgeons. Clin Otolaryngol Allied Sci. 1996;21(5):404-408. doi: 10.1046/j.1365-2273.1996.00814.x. 8. Kaddour HS. Myringoplasty under local anaesthesia: day case surgery. Clin Otolaryngol Allied Sci. 1992;17(6):567-568. doi: 10.1111/j.1365-2273.1992.tb01720.x. 9. Shoman NM. Clinical and audiometric outcomes of palisade cartilage myringoplasty under local anesthetic in an office setting. Am J Otolaryngol. 2019;40(4):482-486. doi: 10.1016/j.amjoto.2019.03.015. 10. Kosucu M, Tugcugil E, Cobanoglu B, Arslan E. Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations. Am J Otolaryngol. 2020;41(6):102619. doi: 10.1016/j.amjoto.2020.102619. 11. Andreassen UK, Larsen CB. Anesthesia in ear surgery: a resource economical analysis and patient assessment of general anesthesia versus local anesthesia in ear surgery. Ugeskr Laeger. 1990;152(22):1595-1597. Available from: PubMed. Article published in Danish. 12. Naina P, Pokharel A, Syed KA, John M, Varghese AM, Kurien M. A three point assessment protocol for tympanoplasty outcomes: a retrospective analysis. Int Arch Otorhinolaryngol. 2020;24(4):e438-e443. doi: 10.1055/s-0039-3402432. 13. Liang S, Irwin MG. Review of anesthesia for middle ear surgery. Anesthesiol Clin. 2010;28(3):519-528. doi: 10.1016/j.anclin.2010.07.009. 14. Wegner I, Bittermann AJ, Zinsmeester MM, van der Heijden GJ, Grolman W. Local versus general anesthesia in stapes surgery for otosclerosis: a systematic review of the evidence. Otolaryngol Head Neck Surg. 2013;149(3):360-365. doi: 10.1177/0194599813493393. 15. Controlled hypotension with desflurane combined with esmolol or dexmedetomidine during tympanoplasty in adults: a double-blind, randomized, controlled trial. Curr Ther Res Clin Exp. 2014. Available from: PubMed.