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临床试验/NCT01141036
NCT01141036已完成不适用

Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Exacerbation of hepatic encephalopathy

研究概览

简要总结

Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.

详细描述

Background : Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. AIM: The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. Methods: 60 outpatients who has known chronic liver disease (Child-Pugh class A or B) (cirrhosis) and are undergoing variceal screening will be randomized to receive propofol or midazolam for sedation. Administration of sedation was performed by a anesthesist. Outcome measures studied are induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function and subclinical hepatic encephalopathy (number connection test), and saturation of oxygen. expected results: The mean time to achieve adequate sedation will be shorter for for the propofol group in comparison to midazolam group. The level of sedation achieved by the propofol group will be greater. Time to full recovery will be faster in the propofol group. Propofol do not exacerbate subclinical hepatic encephalopathy as compared to midazolam. patients receiving propofol will express greater overall mean satisfaction with the quality of their sedation at the time of discharge. Conclusions: Propofol sedation is expected not to exacerbate subclinical hepatic encephalopathy in cirrhotics.

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
Single (Participant)

入排标准

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

入选标准

  • Known chronic liver disease (Child-Pugh class A or B) who presented for upper GI endoscopy for routine variceal screening.
  • The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available.
  • Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites.

排除标准

  • Exclusion criteria will include the following:
  • known allergy or adverse reaction to sedative or component thereof
  • patients with known significant respiratory disease or airway abnormality)
  • active neurological impairment including clinically detectable hepatic encephalopathy
  • advanced or decompensated liver disease ( CP score >10, MELD >24) (Child-Pugh class C)
  • active alcohol consumption or illicit drug abuse
  • active prescription for sedation or narcotics

研究组 & 干预措施

propofol

Active Comparator

propofol

干预措施: propofol (Drug)

Midazolam

Active Comparator

Midazolam

干预措施: Midazolam (Drug)

结局指标

主要结局

Exacerbation of hepatic encephalopathy

次要结局

  • Recovery time, time to discharge

研究者

发起方
Ziv Hospital
申办方类型
Other Gov

研究点 (1)

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