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临床试验/NCT00326352
NCT00326352终止不适用

Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
2
主要终点
Time to full recovery

研究概览

简要总结

For reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam

详细描述

Propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. We intend to provide sedation with propofol, 0.5 mg/Kg, and analgesia with remifentanil 0.5 microgram/Kg for reduction of dislocated shoulders. This will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/Kg, and morphine incrementally up to 0.15 mg/Kg. The primary outcome measure is time to full recovery. Secondary aspects are pain or discomfort during the procedure and operating conditions.

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
None

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anterior dislocation of the shoulder suitable for manual reduction

排除标准

  • significant other illness
  • body weight 25% greater than expected
  • fear of oxygen masks
  • alcohol intoxication

结局指标

主要结局

Time to full recovery

次要结局

  • Operating conditions
  • Pain or discomfort

研究者

申办方类型
Other

研究点 (2)

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