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OpenTrials
Completed

NCT Number: NCT03941847

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uteza

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

listening music

Primary outcomes

  1. quantity of propofol

    Time frame: 2 months

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

Secondary outcomes

  1. Quantity of morphinomimetics

    Time frame: 2 months

    Quantity of morphinomimetics (morphine equivalent) used in mg for anesthetic induction.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: MUSINDUC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.