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

NCT ID: NCT06579001

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2025-04-08

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Nasal spray dexmedetomidine

Intervention Type: DRUG

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

Saline group

Normal saline packaged in the same appearance was used

Group Type: PLACEBO_COMPARATOR

Nasal spray dexmedetomidine

Intervention Type: DRUG

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

Interventions

Nasal spray dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

saline

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

闗闗

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Min Yan

Role: CONTACT

zryanmin@zju.edu.cn

0571-87783759

Facility Contacts

Role: primary

zryanmin@zju.edu.cn

Other Identifiers

2024-0592

Identifier Type: -

Identifier Source: org_study_id