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MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)

NCT07538284 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Major Abdominal Surgery
  • Postoperative Delirium (POD)
  • Sleep Disturbances
  • Intranasal Dexmedetomidine

Interventions

DRUG

Dexmedetomidine

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).

DRUG

Placebo

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).

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538284 on ClinicalTrials.gov