NCT07695285

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
992

participants targeted

Target at P75+ for phase_2

Timeline
41mo left

Started Sep 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 6, 2026

Last Update Submit

July 12, 2026

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • The incidence of POD

    The incidence of POD within 5 days after surgery

    The 1st to 5th day after the operation

Secondary Outcomes (1)

  • Postoperative sleep quality（The Richards-Campbell Sleep Questionnaire）

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

Study Arms (2)

The intervention group

EXPERIMENTAL
Drug: Lemborexant Pill

The control group

PLACEBO COMPARATOR
Drug: Placebo tablet

Interventions

Lemborexant PillDRUG

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

The intervention group
Placebo tabletDRUG

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

The control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60 years old;
  • ASA classification I to III;
  • Patients undergoing elective surgery;
  • Sign the informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Interventions

lemborexant

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

July 14, 2026

Record last verified: 2026-07