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MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
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.
Official title: Minimizing Delirium With Nasal Dexmedetomidine-Induced Sleep in Older Patients Undergoing Major Abdominal Surgery: : a Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
65 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-05-01
Completion Date
2027-06-30
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
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).
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).