SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6,963
- 试验地点
- 1
- 主要终点
- Number of subjects who experience desaturation
研究概览
简要总结
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
详细描述
A variety of sedatives are available in procedural sedation and the efficacy & safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Midazolam
Midazolam group
干预措施: Midazolam (Drug)
Dexmedetomidine
Dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
propofol
propofol group
干预措施: Propofol (Drug)
Midazolam/Propofol
Midazolam and Propofol group
干预措施: Midazolam/Propofol (Drug)
结局指标
主要结局
Number of subjects who experience desaturation
时间窗: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.
SaO2 \< 94% for more than 10 seconds, RR\<8, apneic episodes, face mask
次要结局
- Number of subjects who experience Hypotension(From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure)
- Number of subjects who experience Bradycardia(From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure)