跳至主要内容
临床试验/NCT02618668
NCT02618668终止2 期

Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
90
试验地点
1
主要终点
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography

研究概览

简要总结

The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient & doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists ( I ,II )

排除标准

  • Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
  • History of substance abuse or dependence.
  • History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.

研究组 & 干预措施

Ketamine / Propofol Admixture

Experimental

Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol.

干预措施: Ketamine / Propofol Admixture (Drug)

Propofol

Active Comparator

I.V propofol 2 mg/kg

干预措施: Propofol (Drug)

结局指标

主要结局

mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography

时间窗: every 5 minutes up to 30minutes

saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography

时间窗: every 5 minutes up to 30 minutes

Heart rate( beat/minute) from baseline of patient

时间窗: every 5 minutes up to 30 minutes

Recovery score of patient

时间窗: up to 10 minutes after the end of procedure

次要结局

  • patient and doctor satisfaction score(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

m mostfa youssef mekky

resident of anesthesia and ICU, Assiut University

Assiut University

研究点 (1)

Loading locations...

相似试验