Delirium
Conditions
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.
Interventions
DRUGacetaminophen
we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen
Sponsors
Montreal Heart Institute
University of Manitoba
Canadian Institutes of Health Research (CIHR)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
blinded medication with codes kept in the pharmacy
Intervention model description
randomized double blind double dummy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
Exclusion criteria
* • 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary Contactsheldon magder, MD
Outcome results
None listed