Using nasal spray dexmedetomidine to prevent emergence delirium after hip replacement surgery
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia: a Randomized Clinical Trial
This study tests if a nasal spray of dexmedetomidine can help older patients avoid confusion and agitation after hip replacement surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT06579001 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of nasal spray dexmedetomidine in preventing emergence delirium in elderly patients undergoing total hip replacement surgery. Emergence delirium is a common postoperative complication characterized by acute brain dysfunction, which can lead to various adverse outcomes. The study aims to determine if administering dexmedetomidine via nasal spray can reduce the incidence of this condition compared to traditional intravenous methods. The research focuses on patients aged 60 and older who are undergoing surgery under general anesthesia.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and older who are scheduled for total hip arthroplasty under general anesthesia.
Not a fit: Patients with severe cardiac issues, allergies to dexmedetomidine, or preoperative delirium may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of emergence delirium and improve postoperative recovery for elderly patients.
How similar studies have performed: Previous studies have shown that intranasal dexmedetomidine can improve perioperative outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou
- 闗闗 — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Min Yan
- Email: zryanmin@zju.edu.cn
- Phone: 0571-87783759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.