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

NCT ID: NCT03941847

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2019-08-31

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.

Conditions

Music, Anesthetic, Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

music

The experimental group will benefit from musical listening during a classic period of induction of anesthesia

Group Type: EXPERIMENTAL

music

Intervention Type: OTHER

listening music

silence

The control group will have a usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

music

listening music

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uteza

Caen, Normandy, France

Countries

France

Other Identifiers

CHU 19-007

Identifier Type: -

Identifier Source: org_study_id