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

Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Drug: Nasal spray dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: 0571-87783759; Email: zryanmin@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • 闗闗
    • Contact: Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Nasal spray dexmedetomidine; Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment; Other Names: saline
Placebo Comparator: Saline group; Normal saline packaged in the same appearance was used	Drug: Nasal spray dexmedetomidine; Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergency delirium	RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire	postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Min Yan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): April 8, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 2024-0592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No