Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06579001
Phase
PHASE4
Status
Recruiting
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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nasal spray dexmedetomidine — DRUG
    Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment

Study Details

Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.

Key Dates

First listed
Aug 30, 2024
Start date
Nov 21, 2024
Status verified
Jul 2024
Primary completion
Mar 31, 2025
Completion
Apr 8, 2025

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dex group
    at least 20 min before the introduction of anesthesia, the patient takes the sitting position, the head is slightly tilted forward, and the product is kept upright. Insert the nostril at the same Angle as the nasal cavity. Press down on the spray pump evenly with the index and middle fingers at the same time, and press the pump to the bottom at one time for 1 spray (25ug). After 1 spray on both nostrils, tilt your head back slightly and inhale gently. After staying for about 30 s, 1 spray was applied to each nostril on both sides for a total of 4 sprays (100ug).
  • Placebo Comparator: Saline group
    Normal saline packaged in the same appearance was used

Primary Outcome Measure

emergency delirium [ Time Frame: postoperative ]

Central Contacts

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