Evaluation of the Effect of Musical Listening on Hypnotic Savings During the Induction of General Anesthesia

Not Applicable

Completed

• Conditions: Music, Anesthetic, Induction
• Interventions: Other: music

• Registration Number: NCT03941847
• Lead Sponsor: University Hospital, Caen

Brief Summary

Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.

Objective :

We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.

Materials and methods :

Randomized, prospective, monocentric study

2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.

The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.

This study should include 104 subjects (52 in each group) requiring general anesthesia.

Hypothesis tested:

Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-06
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Patient presenting for surgery under general anesthesia in ophthalmic surgery, ENT, CMF and neurosurgery (lumbar and cervical disc hernia, neurostimulator insertion, vertebral cementoplasty)
• Score ASA 1, 2, 3.
• Intervention time < 3 hours.

Exclusion Criteria

• Patients under 18 years of age
• Patient under guardianship or curatorship
• Refusal of the patient
• Deaf patient
• Non-cooperating patient
• Anesthetic protocol different from that standardised

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music	music	The experimental group will benefit from musical listening during a classic period of induction of anesthesia

Primary Outcome Measures

Name	Time	Method
quantity of propofol	2 months	quantity of propofol in mg/kg necessary for the induction of general anaesthesia

Secondary Outcome Measures

Name	Time	Method
Quantity of morphinomimetics	2 months	Quantity of morphinomimetics (morphine equivalent) used in mg for anesthetic induction.

Trial Locations

Locations (1)

Uteza; 🇫🇷 Caen, Normandy, France