Evaluation of the Effect of Musical Listening on Hypnotic Savings During the Induction of General Anesthesia
NCT03941847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2022-08-24
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
Interventions
- OTHER
-
music
listening music
Sponsors & Collaborators
-
University Hospital, Caen
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-06
- Primary Completion
- 2019-06-30
- Completion
- 2019-08-31
Countries
- France
Study Locations
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