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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorBeijing Tiantan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

992 Participants
are divided into 2 treatment groups
Group A: The intervention groupExperimental treatment 1 intervention
Group B: The control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of POD

The incidence of POD within 5 days after surgery

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

Secondary outcomes

1

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.

Time frame
On the 1st, 3rd and 5th days after the operation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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