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

Study Overview
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Brief Summary
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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.

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

Conditions
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Music, Anesthetic, Induction

Intervention / Treatment
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* Other: music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |