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

Phase 4

Recruiting

• Conditions: Delirium
• Interventions: Drug: Nasal spray dexmedetomidine

• Registration Number: NCT06579001
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

The incidence of hip fracture after surgery in patients over 55 years old is about 45%, and ED is highly predictive of delirium during postoperative hospitalization, which occurs in about 1/3 of ED patients during postoperative hospitalization.

It has been suggested that if delirium is monitored only on the first postoperative day and not at the PACU stage, up to 53% of delirium cases may be missed.

Studies have shown that perioperative application of dexmedetomidine can reduce the risk of postoperative delirium to a certain extent. However, intravenous dexmedetomidine usually leads to problems with delayed extubation, residual sedation, and prolonged PACU stay.

Previous studies have shown that intranasal dexmedetomidine improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing laparoscopic gynecologic surgery. Compared with intravenous administration, intranasal administration of dexmedetomidine resulted in milder hemodynamic fluctuations. However, stable nasal spray bioavailability is superior to intravenous dosage forms for nasal use.

Based on the above background, this study aims to investigate the effect of nasal spray of dexmedetomidine on the prevention of emergence delirium after total hip replacement in elderly patients.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Study Start: 2024-11-21
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Age ≥60 years old
2. Total hip arthroplasty under general anesthesia
3. ASA II-III
4. Informed consent was obtained from patients or their guardians

Exclusion Criteria

1. Allergy or contraindication to dexmedetomidine
2. Severe rhinitis and nasal deformity
3. Severe bradycardia (heart rate <50 beats/minute) or atrioventricular block of grade 2 or higher, permanent pacemaker implantation, severe heart failure or ejection fraction <30%
4. Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
5. Emergency surgery
6. Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
7. Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
8. Preoperative delirium was present

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex group	Nasal spray dexmedetomidine	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).
Saline group	Nasal spray dexmedetomidine	Normal saline packaged in the same appearance was used

Primary Outcome Measures

Name	Time	Method
emergency delirium	postoperative	RASS\&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire

Secondary Outcome Measures

Name	Time	Method
Preoperative anxiety score	preoperative	Perioperative anxiety scale，PAS-7, score range: 0-28, higher score means more anxiety
Postoperative delirium	postoperative 3 days	3D-CAM,delirium was judged according to whether there were positive features in the questionnaire
time to extubation	postoperative 3 days	time to extubation
PACU stay	postoperative 3 days	length of PACU stay
Hemodynamic changes	introperative	between drug administration and anesthesia introduction
PONV	postoperative 3 days	the incidence of nausea and /or vomiting
sleep quality	postoperative 3 days	RCSQ, 0-100, higher score means higher sleep quality
Pain score	postoperative 3 days	NRS, 0-10, 0 means no pain, 10 means severe pain

Trial Locations

Locations (1)

闗闗; 🇨🇳 Hangzhou, China