About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥60 years old;
ASA classification I to III;
Patients undergoing elective surgery;
Sign the informed consent form.
Disqualifiers
Tracheal intubation is expected to be retained after the operation;
Previous history of alcohol or drug abuse;
Severe abnormalities in liver and kidney functions;
Long-term use of sedative-hypnotic drugs;
Trial design
Parallel
Treatments tested in this trial
Lemborexant Pill
DrugThe intervention group will take Lemborexant tablets four times during the perioperative period
Placebo tablet
DrugThe control group will take placebo tablets with the same appearance, smell and properties as the intervention group four times during the perioperative period
Treatment groups
Trial outcomes
Primary outcomes
The incidence of POD
The incidence of POD within 5 days after surgery
Secondary outcomes
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: