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临床试验/NCT06358131
NCT06358131招募中1 期

Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy.

Mansoura University4 个研究点 分布在 1 个国家目标入组 656 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
656
试验地点
4
主要终点
Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.

研究概览

简要总结

There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal [GI] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal [GI] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age18 to 80 American Society of Anesthesiologists (ASA) class I-II Informed consent. Patients scheduled for upper and lower endoscopy.

排除标准

  • Chronic use of drugs as benzodiazpines, neuroleptics and anticonvulsants for more than 30 days.
  • Hypersensitivity reactions to drugs used in the study. Psychiatric patients. Pregnancy. Being submitted to endoscopy as an emergency procedure.

结局指标

主要结局

Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.

时间窗: 2 years

次要结局

  • Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.(2 years)

研究者

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

Asmaa Gameel

Dr

Mansoura University

研究点 (4)

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