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

C

Caen University Hospital

Status

Completed

Conditions

Music, Anesthetic, Induction

Treatments

Other: music

Study type

Interventional

Funder types

Other

Identifiers

NCT03941847
CHU 19-007

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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