跳至主要内容
临床试验/NCT01617707
NCT01617707终止不适用

Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam

Yonsei University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年5月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
Satisfaction of endoscopists, nurses and patients

研究概览

简要总结

Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • patient who consents to enroll the trial

排除标准

  • age < 20
  • pregnant or lactating women
  • American Society of Anesthesiology (ASA) physical status class V
  • chronic pulmonary disease
  • history of allergic to propofol
  • history of complication of sedation endoscope
  • liver failure or hepatic encephalopathy
  • who didn't consented to enroll the trial

研究组 & 干预措施

conventional sedation group

Active Comparator

midazolam

干预措施: Midazolam (Drug)

BPS group

Experimental

midazolam plus propofol

干预措施: Midazolam plus propofol (Drug)

结局指标

主要结局

Satisfaction of endoscopists, nurses and patients

时间窗: about 5 minutes after the end of the procedure

endoscopists and nurses - about 5 minutes after the end of the procedure / patients - upon meeting discharge criteria (modified Aldrete score), an expected average of 20min

次要结局

  • completion rate of endoscopy(about 5 minutes after the end of procedure)
  • number of participants with complications(participants will be followed during the procedure and recovery time, an expected average of 20 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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