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

Music, Anesthetic, Induction Clinical Trial

— MUSINDUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941847
• Other study ID #: CHU 19-007
• Status: Completed
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Music, Anesthetic, Induction

Intervention

Other:
• music
listening music

Locations

Country	Name	City	State
France	Uteza	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantity of propofol	quantity of propofol in mg/kg necessary for the induction of general anaesthesia	2 months
Secondary	Quantity of morphinomimetics	Quantity of morphinomimetics (morphine equivalent) used in mg for anesthetic induction.	2 months