Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial

Mar 11, 2021BMJ open

Regular 6-Hourly IV Acetaminophen to Prevent Delirium After Heart Surgery in Older Patients: Trial Plan

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Abstract

In a trial involving 900 older cardiac surgical patients, the effect of scheduled 6-hourly acetaminophen administration on will be evaluated.

Scheduled acetaminophen administration may influence the incidence of in-hospital delirium up to 30 days post-surgery.
Secondary outcomes will assess the duration and severity of delirium experienced by patients.
The trial will also explore the impact of acetaminophen on hospital and ICU lengths of stay.
Postoperative pain scores and rescue analgesic consumption will be monitored as part of the evaluation.
Long-term neurocognitive outcomes and chronic sternal pain will be investigated as part of the study.

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INTRODUCTION: is common among older cardiac surgery patients. Often difficult to predict and address prophylactically, delirium complicates the postoperative course by increasing morbidity and mortality as well as prolonging both hospital and intensive care unit (ICU) lengths of stay. Based on our pilot trial, we intend to study the effect of scheduled 6-hourly acetaminophen administration for 48 hours post-cardiac surgery with cardiopulmonary bypass (CPB) on the incidence of in-hospital delirium and long-term neurocognitive outcomes. Additionally, effect on duration and severity of delirium, rescue analgesic consumption, acute and chronic pain scores and lengths of hospital and ICU stay will also be explored.

METHODS AND ANALYSIS: This multicentre, randomised, placebo-controlled, quadruple-blinded trial will include 900 older (>60 years) cardiac surgical patients requiring CPB. Patients meeting the inclusion criteria and not meeting any exclusion criteria will be enrolled at seven centres across the USA with Beth Israel Deaconess Medical Center (BIDMC), Boston, as the central coordinating centre. Additional sites may be included to broaden or speed accrual. The primary outcome measure is the incidence of in-hospital delirium till day 30. Secondary outcomes include the duration and severity of in-hospital delirium, hospital and ICU lengths of stay, postoperative pain scores, postoperative rescue analgesic consumption, postoperative cognitive function and chronic sternal pain. Creation of a biorepository and the use of intraoperative-blinded electroencephalogram (EEG) and cerebral oximetry data will support exploratory endpoints to determine mechanistic predictors of postoperative delirium.

ETHICS AND DISSEMINATION: This trial is approved and centrally facilitated by the Institutional Review Board at BIDMC. An independent Data Safety and Monitoring Board is responsible for maintaining safety oversight. Protocol # 2019 P00075, V.1.4 (dated 20 October 2020).

TRIAL REGISTRATION NUMBER: NCT04093219.

Key numbers

50%

Incidence of Delirium

Incidence of in older cardiac surgical patients.

900

Sample Size

Total number of older cardiac surgical patients to be enrolled in the trial.

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Scheduled Prophylactic 6-Hourly IV AcetaminopheN to Prevent Postoperative Delirium in Older CaRdiac SurgicAl Patients (PANDORA): protocol for a multicentre randomised controlled trial

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