Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-11

Study Completion Date

2021-06-21

Brief Summary

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

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Detailed Description

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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

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Otosclerosis Otosclerosis Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Local anesthetic

Patients who chose local anesthesia for their surgery

Local anesthetic

Intervention Type DRUG

1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia

General anesthetic

Patients who chose general anesthesia for their surgery

general anesthetic

Intervention Type DRUG

Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Interventions

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Local anesthetic

1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia

Intervention Type DRUG

general anesthetic

Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years suffering from otosclerosis who have surgical indication.
* Patients who want surgical treatment for their otosclerosis
* Clinic : Deafness with social prejudice and normal otoscopic exam
* Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB.
* Pré operative scan in favor of otosclerosis
* Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window

Exclusion Criteria

* History of ear surgery
* No medical objection to local anesthesia
* No medical objection to general anesthesia
* No medical objection to ear surgery
* No legal protection for adults
* No participation refusal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No