Intravenous Acetaminophen After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 8
- 主要终点
- post operative delirium
研究概览
简要总结
Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.
详细描述
Patients > or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex.
We also will assess use of NSAID, specifically ketorolac, and any NSAID associated events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple. blinded medication with codes kept by pharmacy director
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater or equal to 18
- •elective cardiac surgery
- •stable pre-operative
- •aorto-coronary bypass with or without 1 valve replacement.
排除标准
- •Refusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer's disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment
研究组 & 干预措施
Oral Placebo
Subject receives active intravenous acetaminophen and oral placebo acetaminophen
干预措施: acetaminophen (Drug)
Oral Acetaminophen
Subject receives placebo IV fluid (saline) and active oral acetaminophen
干预措施: acetaminophen (Drug)
结局指标
主要结局
post operative delirium
时间窗: up to 7 days
measured with CAMICU or CAM
次要结局
- total use of opioids(up to 7 days)
- Cognitive function at 6 months and 1 year(6 months and 1 year)
- Time in intensive care unit(up to 7 days)
- time in hospital(up to 7 days)
- time to extubation(up to 7 days)
研究者
magder sheldon
Principle Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre