Phase 4
Completed N=121
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery
Source: ClinicalTrials.gov NCT02546765 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Incidence of Delirium — 2; 4; 8; 9 Participants
◆ Published Evidence
Highly cited
312citations · ~45 / year
Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial.
Summary
Investigators will assess the incidence and duration of postoperative delirium in patients ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia. Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or standard postoperative management using IV propofol with morphine or hydromorphone. The Confusion Assessment Method (CAM) will be used to assess delirium in these patients. Investigators also seek to compare postoperative (48 hours) analgesic requirements in patients with or without IV acetaminophen. Investigators will finally assess postoperative cognition in post-surgical patients up to one year post-discharge using a cognitive assessment scale.
Linked Publications (4)
-
Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial.
-
Sex Differences in the Incidence of Postoperative Delirium after Cardiac Surgery: A Pooled Analyses of Clinical Trials.
-
Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial.
-
Multivariable model of postoperative delirium in cardiac surgery patients: proteomic and demographic contributions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Delirium |
2; 4; 8; 9 | — |
| SECONDARY Duration of Delirium |
1; 1; 1; 3 | — |
| SECONDARY Severity of Delirium |
10; 8; 6; 9 | — |
| SECONDARY Postoperative Opioid Consumption in Morphine Equivalents |
10050; 12611; 11382; 12616 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
23; 24; 24; 23 | — |
| SECONDARY Hospital Length of Stay |
8; 8; 9; 8 | — |
| SECONDARY ICU Length of Stay |
28.8; 30.3; 49.1; 29.3 | — |
| SECONDARY Follow up Incidence of Cognitive Dysfunction |
17; 18; 19; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 60 years of age
- Undergoing CABG with/without valve (aortic and/or mitral) procedure requiring bypass
Exclusion Criteria
- Pre-operative Left Ventricular Ejection Fraction (LVEF) 2 mg/dl
- Liver dysfunction (liver enzymes > 4x the baseline, since patients will have a baseline liver function tests), history and exam suggestive of jaundice
- Known history of alcohol or drug abuse (>10 drinks per week)
- Hypersensitivity to any of the study drug and percutaneous procedures
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT02546765) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.