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Effect of perioperative dexmedetomidine nasal spray on postoperative delirium in elderly patients undergoing lower limb fracture surgery: a randomized, double-blind, placebo-controlled multicenter superior efficacy clinical trial

Effect of perioperative dexmedetomidine nasal spray on postoperative delirium in elderly patients undergoing lower limb fracture surgery: a randomized, double-blind, placebo-controlled multicenter superior efficacy clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114122
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium (POD)

Interventions

Dexmedetomidine nasal spray group:Dexmedetomidine nasal spray*3 times
Normal saline group:Normal saline nasal spray*3 times

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with long bone fractures of the lower extremities that undergo elective surgical treatment, including femur, tibia, fibula, or multiple combined fractures. 2. Age >= 65 years old. 3. ASA grade I~III. 4. No cognitive dysfunction or delirium at present. 5. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are expected to have surgery later than 16:00 on the day of surgery. 2. Combined fractures in other parts of the lower limbs, such as head, chest, upper limbs, pelvis, etc. 3. Suffering from severe rhinitis and nasal deformity. 4. Patients with diagnosed neurodegenerative diseases, history of mental illness, inability to communicate normally, and language disorders. 5. Those who have a history of allergy or resistance to alpha2 receptor agonists, or who are using long-acting alpha2 agonists. 6. Those with a history of acute cerebrovascular disease (stroke or cerebral hemorrhage within 6 months). 7. Those who are admitted to the hospital with an electrocardiogram showing 2° or 3° atrioventricular block or bradycardia (heart rate < 50 bpm). 8. Already enrolled in other clinical investigators. 9. Patients who require ventilator treatment after surgery. 10. Other situations that the investigator judges does not meet the requirements of the study according to the specific situation.

Design outcomes

Primary

MeasureTime frame
Delirium incidence within 5 days after surgery;

Secondary

MeasureTime frame
Sleep quality;Postoperative rehabilitation and the occurrence and outcome of complications;Anesthesia and blood indicators;quality of early postoperative recovery;intraoperative BIS and EEG of the patient.;occurrence of adverse events.;Time from surgery to discharge and cost;pain;

Countries

China

Contacts

Public ContactHuang Lina

Shanghai General Hospital

honilla@163.com+86 21 6324 0090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026