Postoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in depressed patients. However, the role of S-ketamine in preventing postoperative delirium is still unknown. Therefore, this study aims to evaluate the effect of intraoperatively prophylactic S-ketamine compared to dexmedetomidine on the incidence of postoperative delirium in elderly patients undergoing non-cardiac thoracic surgery.
Postoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in depressed patients. However, the role of S-ketamine in preventing postoperative delirium is still unknown. Therefore, this study aims to evaluate the effect of intraoperatively prophylactic S-ketamine compared to dexmedetomidine on the incidence of postoperative delirium in elderly patients undergoing non-cardiac thoracic surgery. This will be a randomized, double-blinded, placebo-and positive-controlled, non-inferiority trial that enrolls patients aged 60 or over undergoing thoracic surgery. The primary outcome will be the incidence of postoperative delirium within 4 days after surgery and assessed using a 3-minute Diagnostic Confusion Assessment Method (3D-CAM) twice a day. Secondary outcomes included postoperative delirium severity, motroic subtypes, episodes, and duration. Additional prespecified outcomes were emergence delirium; time to delirium onset; time to extubation; postoperative pain intensity at rest and during cough at 4, 24, and 48 h postoperatively; postoperative opioid consumption and rescue analgesia requirements; subjective sleep quality within the initial 4 days after surgery; postoperative length of hospital stay; and cognitive function and mortality at 30- and 90-day follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
520
Loading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h
Loading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h
Cancer hospital and institute of Guangzhou medical university
Guangzhou, Guangdong, China
Number of Patients With Post-operative Delirium in 4 Days After Surgery
3-minute Diagnostic Confusion Assessment Method (3D-CAM)
Time frame: Within 4 days after surgery
Severity of Delirium
Confusion Assessment Method- Severity (CAM-S, Mild-to-moderate delirium will be defined as a CAM-S score of 3 to 5, while severe delirium will be defined as a CAM-S score of 6 to 7)
Time frame: Within 4 days after surgery
Duration of postoperative delirium
Positive days of postoperative delirium
Time frame: Within 4 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.