Abstract
BackgroundPostoperative 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT02546765, registered January 13, 2015.
Highlights
Postoperative delirium is common in elderly cardiac surgery patients
The incidence of delirium varies with the setting and the population analyzed and is reported to be as high as 82% in the intensive care unit (ICU) [2]
This study explores the effect of cardiopulmonary bypass and its inflammatory response leading to erythrocyte lysis and the effect of acetaminophen on its prevention [25]
Summary
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. Risk factors for delirium in patients undergoing cardiac surgery include pre-existing cognitive dysfunction, depression, transient ischemic attacks, and abnormal serum albumin [6]. The interplay between these pre-existing comorbid conditions and numerous perioperative factors, including postoperative pain, mechanical ventilation, use of deliriogenic analgesic and sedative drugs, and the inflammatory response to surgery and cardiopulmonary bypass, makes the elderly especially vulnerable to delirium. The pathogenesis of postoperative delirium is not completely understood, modifiable factors such as perioperative sedation and opioid-based analgesia may contribute to the etiology [7, 8]
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