Balloon Dilation Eustachian Tuboplasty Combined with Tympanotomy Tube Insertion for Treatment of Refractory Otitis Media with Effusion: A Randomized, Prospective, Controlled Trial Comparing Local Anesthesia Combined Sedation Versus General Anesthesia.

BACKGROUND Balloon dilation eustachian tuboplasty (BET) is used to treat eustachian dysfunction but its therapeutic effect and cost-effectiveness when combined with tympanotomy tube insertion (TBI) on refractory otitis media with effusion under local anesthesia with sedation compared to traditional general anesthesia are not well understood. MATERIAL AND METHODS Forty patients with refractory secretory otitis media who received BET+TBI were enrolled in this study and randomized into the local anesthesia with sedation group (n=20) and general anesthesia group (n=20). Tympanometry (TMM), 7-item eustachian tube dysfunction questionnaire (ETDQ-7) results, intraoperative anesthesia accidents, and operation costs were compared between the groups. RESULTS Patients in the local anesthesia with sedation group exhibited intraoperative awareness and pain. Differences in TMM, ETDQ-7 results, and postoperative VAS scores between the groups were comparable (P>0.05). Notably, operative time and treatment costs in the local anesthesia group were lower compared with general anesthesia group. CONCLUSIONS The treatment effects and safety of local anesthesia and general anesthesia under BET combined with TBI for treatment of refractory otitis media with effusion are comparable. However, further studies should aim at reducing pain and discomfort.