NCT06579001 Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement
| NCT ID | NCT06579001 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 264 participants in total. It began in 2024-11-21 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Min Yan
STUDY DIRECTOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT06579001 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06579001 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06579001 currently recruiting?
Yes, NCT06579001 is actively recruiting participants. Contact the research team at zryanmin@zju.edu.cn for enrollment information.
Where is the NCT06579001 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06579001 clinical trial?
NCT06579001 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Min Yan at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 264 participants.