NCT07538284

Brief Summary

This study aims to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
14mo left

Started May 2026

Shorter than P25 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

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

May 30, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

May 30, 2025

Last Update Submit

April 12, 2026

Conditions

Major Abdominal SurgeryPostoperative Delirium (POD)Sleep DisturbancesIntranasal Dexmedetomidine

Keywords

dexmedetomidineintranasal administration

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    Confusion Assessment Method

    Up to postoperative day (POD) 7 or discharge (whichever first).

Secondary Outcomes (10)

  • Delirium severity

    Up to postoperative day (POD) 7 or discharge (whichever first)

  • Physical activity

    Up to postoperative day (POD) 3

  • Sleep quality

    Up to postoperative day (POD) 3

  • Anxiety

    Up to postoperative day (POD) 3

  • Pain intensity

    Up to postoperative day (POD) 3

  • +5 more secondary outcomes

Other Outcomes (3)

  • Optional intranasal administration on the night of surgery

    At night of the surgery

  • Length of Hospital Stay

    From postoperative day 0 until date of hospital discharge (Up to 30 days)

  • Cognitive function

    Up to postoperative day (POD) 30

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DexmedetomidineDRUG

Intranasal dexmedetomidine (100 µg total: 4 sprays, 25 µg/spray; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).

Dexmedetomidine
PlaceboDRUG

Intranasal water for injection (4 sprays, identical volume as nasal dexmedetomidine; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).

Placebo

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65-90 years
  • Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours

You may not qualify if:

  • Blind, deafness or the inability to speak mandarin
  • Allergy to dexmedetomidine.
  • Renal and liver failure requiring dialysis or Child-Pugh score \> 5
  • Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
  • Previous major abdominal or cardiac surgery within 1 year of surgical procedure
  • Chronic therapy with benzodiazepines and/or antipsychotics. Severe deficit due to structural or anoxic brain damage
  • Body weight \< 35 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence DeliriumParasomnias

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Mentying Ding, MD.

CONTACT

+86-1517037567915170375679@163.com

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
Professor

Study Record Dates

First Submitted

May 30, 2025

First Posted

April 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to ruanxc@mail.sysu.edu.cn.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Immediately