跳至主要内容
临床试验/NCT04597268
NCT04597268已完成不适用

Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年11月1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
已完成
发起方
入组人数
75
试验地点
1
主要终点
Ramsy sedation score (RSS)

研究概览

简要总结

This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

详细描述

Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal 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
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for gastrointestinal endoscopic procedures
  • ≥ Age 18 years

排除标准

  • Allergy to any of the used drugs
  • impaired renal or liver functions
  • hypertensive patients
  • patients with cardiovascular
  • cerebrovascular disease

研究组 & 干预措施

dexmedetomidine

Experimental

IV dexmedetomidine

干预措施: Dexmedetomidine (Drug)

ketamine

Experimental

IV ketamine

干预措施: Ketamine (Drug)

Midazolam

Active Comparator

IV midazolam

干预措施: Midazolam (Drug)

结局指标

主要结局

Ramsy sedation score (RSS)

时间窗: 3 to 6 months

time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus

次要结局

未报告次要终点

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Walaa Youssef Elsabeeny

Lecturer of anesthesia and pain management

National Cancer Institute, Egypt

研究点 (1)

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