A total of 200 patients will be enrolled to assess the impact of monitoring on after off-pump CABG.
Intraoperative management will be informed by cerebral oxygen saturation levels in the intervention group.
A drop of more than 20% from baseline or saturation below 55% will trigger intervention strategies.
The primary outcome is the incidence of postoperative delirium within the first 7 days following surgery.
Delirium will be evaluated using established scales for agitation and confusion in the ICU.
Secondary outcomes include rates of acute kidney injury and myocardial infarction, as well as length of stay in the ICU and hospital.
Simplified
INTRODUCTION: is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG. 2
METHODS: This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSOless than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay. 2
ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022-1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER: ChiCTR2300068537.
Key numbers
20–50%
Incidence of
Rate of in elderly surgical patients after CABG.
200
Participants
Total number of patients to be enrolled in the trial.
1:1
Allocation ratio
Ratio for random assignment to intervention or control groups.
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