Postoperative Delirium
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLemborexant Pill
The intervention group will take Lemborexant tablets four times during the perioperative period
DRUGPlacebo tablet
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group four times during the perioperative period
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥60 years old; * ASA classification I to III; * Patients undergoing elective surgery; * Sign the informed consent form.
Exclusion criteria
* 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; * Severe sleep apnea and COPD; * Inability to cooperate in mental state; * Craniocerebral surgery * Pregnant and lactating patients; * Use drugs that affect orexin metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of POD | The 1st to 5th day after the operation | The incidence of POD within 5 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative sleep quality（The Richards-Campbell Sleep Questionnaire） | On the 1st, 3rd and 5th days after the operation | 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. |
Outcome results
None listed