跳至主要内容
临床试验/NCT03941847
NCT03941847已完成不适用

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

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
quantity of propofol

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

quantity of propofol

时间窗: 2 months

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

次要结局

  • Quantity of morphinomimetics(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验