Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07695285

Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lemborexant Pill

Drug

The intervention group will take Lemborexant tablets four times during the perioperative period

Placebo Tablet

Drug

The control group will take placebo tablets with the same appearance, smell and properties as the intervention group four times during the perioperative period

Primary outcomes

  1. The incidence of POD

    Time frame: The 1st to 5th day after the operation

    The incidence of POD within 5 days after surgery

Secondary outcomes

  1. Postoperative sleep quality(The Richards-Campbell Sleep Questionnaire)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.