Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in arterial oxygenation
研究概览
简要总结
Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP.
The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem.
The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol.
The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 75 year of age
- •Having ERCP
- •Agrees to take part in the study
排除标准
- •>75 years of age
- •allergy to propofol or doxapram
- •Chronic Obstructive Pulmonary disease (COPD)
- •Coronary artery disease (symptomatic)
- •alcoholism
- •declines to take part in the study
研究组 & 干预措施
Doxapram
Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure
干预措施: Doxapram (Drug)
Placebo
Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Change in arterial oxygenation
时间窗: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward
Hypoxemia, oxygen saturation by pulse oximetry (SpO2 \<90%), considered as a significant change
次要结局
- change in systolic arterial pressure(values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward)
- Pulse (heartbeats/minute)(values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward)
- breathing rate (breaths/minute)(values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure)
研究者
Jarno Jokelainen, MD
Senior physician
Helsinki University Central Hospital