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

July 12, 2026 updated by: Ruquan Han, Beijing Tiantan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

992

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group
Drug: Lemborexant Pill
The intervention group will take Lemborexant tablets four times during the perioperative period
Placebo Comparator: The control group
Drug: Placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of POD
Time Frame: The 1st to 5th day after the operation
The incidence of POD within 5 days after surgery
The 1st to 5th day after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the 1st, 3rd and 5th days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025-476-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe