Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Patient tolerance to the procedure
研究概览
简要总结
Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown. The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or without conscious sedation/analgesia.
详细描述
Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to receive either placebo or midazolam (0.02 mg/kg) or 0.02 mg/kg midazolam combined with 1 mg/kg pethidine before the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •suspected liver disease
- •known liver disease
排除标准
- •liver transplants
- •hepatocellular carcinoma
- •hypersensitivity or allergy to benzodiazepines or morphinic derivatives
研究组 & 干预措施
2
midazolam
干预措施: midazolam (Drug)
2
midazolam
干预措施: transjugular liver biopsy (Procedure)
1
干预措施: transjugular liver biopsy (Procedure)
1
干预措施: placebo (Drug)
3
midazolam + pethidine
干预措施: transjugular liver biopsy (Procedure)
3
midazolam + pethidine
干预措施: midazolam + pethidine (Drug)
结局指标
主要结局
Patient tolerance to the procedure
时间窗: 1 hour after the procedure
次要结局
未报告次要终点