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

Zhejiang University

Status and phase

Enrolling

Phase 4

Conditions

Delirium

Treatments

Drug: Nasal spray dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06579001

2024-0592

Details and patient eligibility

About

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.

Full 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.

Enrollment

264 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Allergy or contraindication to dexmedetomidine
Severe rhinitis and nasal deformity
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%
Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
Emergency surgery
Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
Preoperative delirium was present

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

264 participants in 2 patient groups, including a placebo group

Dex group

Experimental group

Description:

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).

Treatment:

Drug: Nasal spray dexmedetomidine

Saline group

Placebo Comparator group

Description:

Normal saline packaged in the same appearance was used

Treatment:

Drug: Nasal spray dexmedetomidine