IV Acetaminophen After Cardiac Surgery - PILOT
- Registration Number
- NCT05246644
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.
- Detailed Description
The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age \< 60 or \>= 60.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- subjects > 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
-
• Refusal by surgeon for inclusion of the patient
- Requested late extubation by anesthesia or surgeon
- Intra-aortic balloon pump
- Sensitivity to acetaminophen
- Pre-operative cognitive dysfunction
- Psychiatric history with active treatment
- Parkinson's disease
- Alzheimer's disease
- Medication for cognitive decline
- History of recent seizures
- Recent history of alcohol misuse
- Creatinine clearance less than 30 ml/min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Acetaminophen acetaminophen subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses Oral acetaminophen acetaminophen subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses
- Primary Outcome Measures
Name Time Method Development of delirium post operatively up to 7 days post operatively Incidence of delirium will be analyzed between patients treated with IV or oral acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM) or CAMICU when in the intensive care unit
- Secondary Outcome Measures
Name Time Method total opioid usage up to 7 days post-operatively tabulation of all opioids normalized to morphine
Numeric pain rating scale up to 48 hours visual pain score from 1 to 10
cognitive function 7 days post-operative, 6 months and 1 year change in cognitive function score by 2 based on the Montreal cognitive assessment
hospital length of stay length of stay is measured from the day of surgery until the day of discharge from hospital in days Days until discharge
Intensive care length of stay ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours hours in ICU
Trial Locations
- Locations (2)
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada