This prospective, randomized controlled trial aims to investigate the perioperative use of lemborexant, an orexin receptor antagonist, for reducing postoperative delirium (POD) in elderly patients undergoing general anesthesia.
Patients in the intervention group will receive lemborexant, while those in the control group will receive a matching placebo. The primary outcome is the incidence of POD within 5 days after surgery. Secondary outcomes include sleep quality on postoperative days 1, 3, and 5, delirium severity and subtype, hospital anxiety and depression scores, quality of emergence from anesthesia, adverse events, and hematological parameters. The expected findings will provide evidence on the safety and efficacy of prophylactic perioperative lemborexant in improving postoperative outcomes in older patients, and will offer a theoretical and practical foundation for future research and clinical application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
992
The intervention group will take Lemborexant tablets four times during the perioperative period
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group four times during the perioperative period
The incidence of POD
The incidence of POD within 5 days after surgery
Time frame: The 1st to 5th day after the operation
Postoperative sleep quality（The Richards-Campbell Sleep Questionnaire）
The Richards-Campbell Sleep Questionnaire (RCSQ) and sleep monitoring equipment will be used for data collection after the operation. The scale comprises five core items evaluating distinct sleep domains: sleep depth, sleep latency, frequency of awakenings, ability to return to sleep, and overall sleep quality. Each item is rated on a 100-mm visual analogue scale (VAS). The total score is calculated as the mean of the five core item scores, yielding a range from 0 to 100. A higher total score indicates better perceived sleep quality. Specifically, a score of 0 represents the worst possible sleep, while a score of 100 represents the best possible sleep.
Time frame: On the 1st, 3rd and 5th days after the operation
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