Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

NCT03888079 | Completed

• 1 other identifier: 35RC18_3061_SPOC
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Otosclerosis; Otosclerosis Surgery

Keywords

Otosclerosis; otosclerosis surgery; local anesthesia; general anesthesia; comfort assessment; Glasgow Benefit Inventory questionnaire; hearing results

Outcome Measures

Primary Outcomes (1)

• Visual comfort scale (EVA type ruler)

  respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery

  10 days after surgery

Secondary Outcomes (1)

• Glasgow Benefit Inventory questionnaire GBI

  3 months after surgery

Study Arms (2)

Local anesthetic

Patients who chose local anesthesia for their surgery

Drug: Local anesthetic

General anesthetic

Patients who chose general anesthesia for their surgery

Drug: general anesthetic

Interventions

Local anesthetic DRUG

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

Local anesthetic

general anesthetic DRUG

Endotracheal intubation, intravenous narcotic agents, and inhaled agents

General anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from otosclerosis who have surgical indication

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Otosclerosis

Interventions

Anesthetics, Local; Anesthetics, General

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Benoit Godey, PH-PD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 25, 2019
• Study Start: January 11, 2019
• Primary Completion: March 3, 2021
• Study Completion: June 21, 2021
• Last Updated: April 5, 2022

Record last verified: 2019-03

Locations

FR (1)