Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lemborexant Pill, Placebo tablet.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Lemborexant Pill
The intervention group will take Lemborexant tablets four times during the perioperative period - 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
Primary outcome measures
- The incidence of POD [Time frame: The 1st to 5th day after the operation]
Secondary outcome measures (1)
- Postoperative sleep quality（The Richards-Campbell Sleep Questionnaire） [Time frame: On the 1st, 3rd and 5th days after the operation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07695285 · KY2025-476-02