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

NCT03941847 | Completed

• 1 other identifier: CHU 19-007
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• quantity of propofol

  quantity of propofol in mg/kg necessary for the induction of general anaesthesia

  2 months

Secondary Outcomes (1)

• Quantity of morphinomimetics

  2 months

Study Arms (2)

music

EXPERIMENTAL

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

Other: music

silence

NO INTERVENTION

The control group will have a usual care.

Interventions

music OTHER

listening music

music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Uteza

Caen, Normandy, 14000, France

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: May 6, 2019
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2019
• Last Updated: August 24, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)