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

Musinduc : Impact of Music During the Period of Anaesthetic Induction - a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Music, Anesthetic, Induction
• Intervention / Treatment: Other: music

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • Uteza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: music; The experimental group will benefit from musical listening during a classic period of induction of anesthesia	Other: music; listening music
No Intervention: silence; The control group will have a usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantity of propofol	quantity of propofol in mg/kg necessary for the induction of general anaesthesia	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of morphinomimetics	Quantity of morphinomimetics (morphine equivalent) used in mg for anesthetic induction.	2 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CHU 19-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No