Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
- Conditions
- Post Operative DeliriumPost Operative PainPost-Op ComplicationPost-cardiac Surgery
- Interventions
- Registration Number
- NCT06613178
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
greater or equal to 18
- elective cardiac surgery
- stable pre-operative
- aorto-coronary bypass with or without 1 valve replacement.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Placebo acetaminophen Subject receives active intravenous acetaminophen and oral placebo acetaminophen Oral Acetaminophen acetaminophen Subject receives placebo IV fluid (saline) and active oral acetaminophen
- Primary Outcome Measures
Name Time Method post operative delirium up to 7 days measured with CAMICU or CAM
- Secondary Outcome Measures
Name Time Method total use of opioids up to 7 days measured for 7 days or until hospital discharge
Cognitive function at 6 months and 1 year 6 months and 1 year Measured with Montreal Cognitive assessment score.
Time in intensive care unit up to 7 days measured in hours
time in hospital up to 7 days measured in days
time to extubation up to 7 days measured in hours
Trial Locations
- Locations (8)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Trillium Health Centre
🇨🇦Mississagua, Ontario, Canada
Sunnybroook Health Centre
🇨🇦Toronto, Ontario, Canada
University of Ottawa
🇨🇦Ottawa, Ontario, Canada
McGill Universtiy Health Centre
🇨🇦Montreal, Quebec, Canada
Universite Montreal
🇨🇦Montreal, Quebec, Canada
University of Laval
🇨🇦Quebec City, Quebec, Canada