Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
BMJ Open. 2021 Mar 10;11(3):e044346. doi: 10.1136/bmjopen-2020-044346.
Postoperative delirium 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.
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.
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).
NCT04093219.
术后谵妄在老年心脏手术患者中很常见。由于术后谵妄通常难以预测和预防性治疗，因此会增加发病率和死亡率，并延长住院和重症监护病房（ICU）的停留时间，从而使术后病程复杂化。基于我们的初步试验，我们计划研究心脏手术后使用心肺旁路（CPB）48 小时内每 6 小时给予扑热息痛的计划给药对院内谵妄和长期神经认知结果的影响。此外，还将探讨对谵妄持续时间和严重程度、解救镇痛剂消耗、急性和慢性疼痛评分以及住院和 ICU 停留时间的影响。
这项多中心、随机、安慰剂对照、四盲试验将纳入 900 名接受 CPB 的老年（>60 岁）心脏手术患者。符合纳入标准且不符合任何排除标准的患者将在美国七个中心入组，其中包括波士顿 Beth Israel Deaconess Medical Center（BIDMC）作为中央协调中心。可能会增加额外的地点以扩大或加速入组。主要结局指标是直至第 30 天的院内谵妄发生率。次要结局包括院内谵妄的持续时间和严重程度、住院和 ICU 停留时间、术后疼痛评分、术后解救镇痛剂消耗、术后认知功能和慢性胸骨疼痛。创建生物库以及使用术中盲法脑电图（EEG）和脑血氧饱和度数据将支持探索性终点，以确定术后谵妄的机制预测因子。
该试验已获得 BIDMC 机构审查委员会的批准和集中管理。一个独立的数据安全和监测委员会负责维持安全监督。方案编号#2019P00075，V.1.4（2020 年 10 月 20 日）。
NCT04093219。
