Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial

Trials. 2018 Jun 22;19(1):326. doi: 10.1186/s13063-018-2718-0.


Background: Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium.

Methods: This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis.

Discussion: This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity.

Trial registration: Identifier: NCT02546765 , registered January 13, 2015.

Keywords: Acetaminophen; Cardiac surgery; Confusion Assessment Method; Coronary artery bypass grafting; Dexmedetomidine; Montreal Cognitive Assessment; Neurocognition; Postoperative delirium; Propofol.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acetaminophen / administration & dosage*
  • Acetaminophen / adverse effects
  • Administration, Intravenous
  • Analgesics, Non-Narcotic / administration & dosage*
  • Analgesics, Non-Narcotic / adverse effects
  • Boston
  • Cardiac Surgical Procedures / adverse effects*
  • Cardiopulmonary Bypass / adverse effects
  • Cognition / drug effects
  • Coronary Artery Bypass / adverse effects
  • Delirium / diagnosis
  • Delirium / etiology
  • Delirium / prevention & control*
  • Delirium / psychology
  • Dexmedetomidine / administration & dosage*
  • Dexmedetomidine / adverse effects
  • Double-Blind Method
  • Drug Administration Schedule
  • Heart Valve Prosthesis Implantation / adverse effects
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Hypnotics and Sedatives / adverse effects
  • Length of Stay
  • Propofol / administration & dosage
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Time Factors
  • Treatment Outcome


  • Analgesics, Non-Narcotic
  • Hypnotics and Sedatives
  • Acetaminophen
  • Dexmedetomidine
  • Propofol

Associated data