跳至主要内容
临床试验/NCT05880459
NCT05880459尚未招募早期 1 期

Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy

Assiut University0 个研究点目标入组 60 人开始时间: 2023年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
60
主要终点
The level of patient sedation

研究概览

简要总结

Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial

详细描述

Endoscopy plays a significant role in the diagnosis and treatment of gastrointestinal diseases. Sedation has been used in clinical practice to make the procedure more comfortable, and improve patient satisfaction by helping patients rest during the procedure. (1) (2) The most common complications in gastrointestinal endoscopy are not related to the procedure, but are related to sedation; they include cardio-respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vaso-vagal episodes (3).

Many studies have reported on use of propofol as a single agent for sedation during endoscopy. However propofol is often used in combination with another agent for other indications. The benefit of propofol in terms of shorter recovery and discharge times and higher patient satisfaction persists, when it is used in combination with other agents.

Propofol has limited analgesic effect and higher doses are often required, when it is used as a single agent for endonoscopy, resulting in higher sedation levels. Thus use of propofol in combination with other agents may be preferable to propofol alone. The combination may be easier to manage due to lower sedation levels and ability to reverse some of the sedation with the use of reversal agents for narcotics (4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
None

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

  • Patients scheduled for GIT endoscopy
  • Age 18-60 years old
  • BMI less than 30

排除标准

  • Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
  • pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer)
  • central nervous system abnormality
  • allergy to the study drugs
  • habitual sedative or analgesic use
  • Anticipated difficult airway.

研究组 & 干预措施

propofol and nalbuphine group

Active Comparator

干预措施: propofol and magnesium sulphate ,propofol and nalbuphine (Drug)

Propofol and magnesium sulfate group

Active Comparator

干预措施: propofol and magnesium sulphate ,propofol and nalbuphine (Drug)

结局指标

主要结局

The level of patient sedation

时间窗: the time of endoscopy

The level of patient sedation using Ramsay sedation agitation score (before induction of sedation (T0), 5 minutes after sedation (T1), 10 minutes after sedation (T2), and then every 30 minutes till complete recovery (T3, T4 and T5) to assess the depth of anesthesia.

次要结局

未报告次要终点

研究者

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

Noura Hasan Attia

Assistant Lecturer

Assiut University

相似试验