Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- The Change of postoperative sleep quality
研究概览
简要总结
The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.
详细描述
The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored during the operation and the first postoperative night
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP
排除标准
- •The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.
研究组 & 干预措施
dexmeditomidine group D
The sedative solution was prepared as a 10µg /ml dexmedetomidine in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery
干预措施: dexmedetomidine (Drug)
Midazolam group M
The sedative solution was prepared as a 0.375mg/ml midazolam or normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery
干预措施: Midazolam (Drug)
结局指标
主要结局
The Change of postoperative sleep quality
时间窗: preoperation, first postoperative night
The bispectral index score (BIS) was monitored during the operation and the first postoperative night
次要结局
未报告次要终点
研究者
Wen-fei Tan
the Anesthesiology Department
China Medical University, China