Ireland
--:--IST
Recruiting Phase 4

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

NCT06613178 · tracked via the Priya Life Science Canada tracker
Phase
Phase 4
Started
2024-07-02
Last updated
2024-09-25

Condition(s) studied

Post Operative DeliriumPost Operative PainPost-Op ComplicationPost-cardiac Surgery

Investigational drug(s) / intervention(s)

acetaminophen →

acetaminophen: Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: greater or equal to 18 * elective cardiac surgery * stable pre-operative * aorto-coronary bypass with or without 1 valve replacement. Exclusion Criteria: 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 \-

Primary outcome measure(s)

  • post operative delirium — up to 7 days
    measured with CAMICU or CAM

Trial sites (8)

FacilityCityRegionStatus
University of British Columbia Vancouver British Columbia Active Not Recruiting
University of Manitoba Winnipeg Manitoba Recruiting
Trillium Health Centre Mississagua Ontario Not Yet Recruiting
University of Ottawa Ottawa Ontario Not Yet Recruiting
Sunnybroook Health Centre Toronto Ontario Not Yet Recruiting
McGill Universtiy Health Centre Montreal Quebec Recruiting
Universite Montreal Montreal Quebec Recruiting
University of Laval Québec Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06613178 on ClinicalTrials.gov ↗ ← All trials in Canada