NCT03888079

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

Detailed description

The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures. All operations will be performed by the same surgeon and the same basic surgical technique. The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .

Conditions

• Otosclerosis
• Otosclerosis Surgery

Interventions

Type	Name	Description
DRUG	Local anesthetic	1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
DRUG	general anesthetic	Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Timeline

• Start date: 2019-01-11
• Primary completion: 2021-03-03
• Completion: 2021-06-21
• First posted: 2019-03-25
• Last updated: 2022-04-05

Locations

1 site across 1 country: France