Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.
This project will study the impact of scheduled administration of IV acetaminophen on the incidence, duration, and severity of postoperative delirium and other important hospital outcomes. Additionally, this trial will evaluate the effects of IV acetaminophen on longer-term postoperative cognitive dysfunction and functional status and develop a biorepository of perioperative samples as a future resource to probe the mechanisms of postoperative delirium. The investigators propose three specific aims by conducting a randomized, triple-blind clinical trial that enrolls 900 patients 60 years of age or older undergoing cardiac surgery. Through this trial, the investigators will determine the effect of IV acetaminophen on; 1. the incidence, duration, and severity of postoperative delirium, 2. the use of opioids and other rescue analgesics in the first 48 postoperative hours, daily pain scores at rest and exertion, and length of stay in the Intensive Care Unit and overall hospital length of stay 3. longer-term (one, six, 12 months) cognitive, physical, and self-care functional recovery after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
900
use of IV tylenol for pain
Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Irvine
Irvine, California, United States
University of California Los Angeles
Los Angeles, California, United States
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Incidence of Charted Delirium
Charted Delirium will be used as a key secondary outcome in addition to the CAM diagnosis. Incidence in patient's chart for diagnoses synonymous with delirium or a change to the patient's baseline mental status as indicated by trigger words associated with a predictive value for delirium
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Duration of delirium
Total number of in-hospital postoperative days in which delirium is present
Time frame: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Severity of delirium
Delirium severity is evaluated both as the peak (highest) and sum CAM-S score over all hospital days
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Time to onset of delirium
Measured in days
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Additional postoperative analgesic requirements
Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents. Total Morphine Equivalent is calculated as the sum of (fentanyl dose × 2.4) + (hydromorphone dose × 4) + morphine dose + (oxycodone dose × 1.5).
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Yale University/Yale New Haven Hospital
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Albert Einstein College of Medicine- Montefiore
The Bronx, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Time frame: First 48 hours postoperatively
Worst daily pain scores with exertion (deep breathing and cough)
Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of stay in the Intensive Care Unit (ICU)
Defined by the number of days admitted in the ICU prior to transfer to the general cardiac surgical floor
Time frame: Measured in days admitted in the ICU, an average of 2 days
Worst daily pain scores at rest
Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Time frame: Participants will be followed for the duration of the hospital stay, an average of 5 days
Length of hospital stay
Defined by the number of days admitted in the hospital following the completion of surgery.
Time frame: Measured in days admitted in the hospital, an average of 6 days
Trajectory of cognitive function over time
Neurocognition will be reported using the Montreal Cognitive Assessment (MoCA) score that ranges from zero (worst possible score) to 30 (best). At one, six, and twelve months postoperatively a telephonic MoCA will be assessed over the phone. The t-MoCA scores range from zero \[worst\] to 22 \[best\]. A hierarchical linear regression model will be used to characterize the trajectory of t-MoCA scores over time.
Time frame: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month, 6 month and 1- year following the date of surgery
Trajectory of physical function over time.
Physical function will be assessed using the Medical Outcomes Study Short Form 12 questionnaire (SF-12) physical composite score at one, six, and twelve months postoperatively assessed over the phone. A hierarchical linear regression model will be used to characterize the trajectory of SF-12 scores over time.
Time frame: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of functional outcomes over time
Functional status (self care) will be assessed using the FuncAQ and FRAIL scale at one, six, and twelve months postoperatively assessed over the phone. A hierarchical linear regression model will be used to characterize the trajectory of FuncAQ and FRAIL scores over time.
Time frame: Participants will be followed at 1 month, 6 month and 1- year following the date of surgery
Trajectory of chronic pain over time
Chronic sternal pain will be assessed using the Numerical Pain Rating Scale (NPRS) at six and twelve months postoperatively assessed over the phone.
Time frame: Participants will be followed at 6 month and 1- year following the date of surgery