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Clinical Trials/NCT03941847
NCT03941847
Completed
Not Applicable

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

University Hospital, Caen1 site in 1 country104 target enrollmentMay 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music, Anesthetic, Induction
Sponsor
University Hospital, Caen
Enrollment
104
Locations
1
Primary Endpoint
quantity of propofol
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2019
End Date
August 31, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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,
  • 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

Outcomes

Primary Outcomes

quantity of propofol

Time Frame: 2 months

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

Secondary Outcomes

  • Quantity of morphinomimetics(2 months)

Study Sites (1)

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