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