The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
研究概览
简要总结
The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.
详细描述
Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer
排除标准
- •ASA physical status classification 3-4
- •Patients with hearing loss or using hearing aids
- •Patients who received narcotic analgesics or sedative drugs within 1 week
- •Patients with alcohol dependence or drug dependence
- •Patients with drug hypersensitivity to dexmedetomidine
- •Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output
- •Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease
- •Patients with liver failure
- •Patients with kidney failure or on dialysis
- •Patients judged to be unsuitable for the clinical trial by the researchers
- •Patients whose actual operation time is less than 30 minutes
结局指标
主要结局
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
时间窗: Intraoperative (During sedation for surgery)
Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)
次要结局
- Observer's Assessment of Alertness/Sedation Scale (0~5)(During sedation for surgery and at post anesthesia care unit (PACU))
- Dexmedetomidine continuous infusion dose(Intraoperative (During sedation for surgery))
- Adverse event(Intraoperative (During sedation for surgery))
- Postanesthesia recovery score (0~10)(At the postanesthesia recovery room)
- Postoperative delirium(From the end of the surgery to the hospital discharge, an average of 1 week)
- Patient State Index (PSi)(Intraoperative (During sedation for surgery))
- Number of patients requiring additional sedatives(Intraoperative (During sedation for surgery))
- Patient satisfaction(Intraoperative (At the time of leaving the operating room))
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital