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Effects of dexmedetomidine nasal spray on the eve of surgery on postoperative delirium in elderly patients undergoing knee/hip arthroplasty: A prospective, double-blind, randomized controlled clinical trial

Effects of dexmedetomidine nasal spray on the eve of surgery on postoperative delirium in elderly patients undergoing knee/hip arthroplasty: A prospective, double-blind, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095414
Enrollment
Unknown
Registered
2025-01-07
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

postoperative delirium

Interventions

Dexmedetomidine Group:Before the patient fell asleep, dexmedetomidine will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on each nostril for a total of 4 s
Saline Group:Before the patient fell asleep, normal saline will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on each nostril for a total of 4 sprays, and

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >= 60 years; 2.ASA grade I-III; 3.Planned to undergo unilateral knee/hip arthroplasty under general anesthesia; 4.Consent to participate in this study and to be followed throughout the postoperative period.

Exclusion criteria

Exclusion criteria: 1. Patients who refused to sign the consent form; 2. Mini-Mental State Examination (MMSE) score <15; 3. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 4. Inability to communicate in the preoperative period (coma, profound dementia, or language barrier); 5. Known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker; 6. Allergic rhinitis and abnormal nasal structure; 7. Serious hepatic dysfunction (Child-Pugh class C); 8. Serious renal dysfunction (undergoing dialysis before surgery); 9. Allergic to dexmedetomidine.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 3 days after surgery;—

Secondary

MeasureTime frame
Duration and severity of delirium;Sleep quality ;Pain score;Anxiety score;Inflammatory markers;Length of hospital stay;Incidence of nausea and vomiting;Analgesic consumption postoperatively;Incidence of rescue analgesia within 24h postoperatively;Quality of recovery postoperatively;Time to first ambulation postoperatively;Incidence of delirium within 7 days after surgery;Incidence of arrhythmia;Incidence of respiratory depression;Incidence of hypoxemia;Incidence of hypertension;Incidence of hypotension;Incidence of nasal mucosal injury;—

Countries

China

Contacts

Public ContactSu Liu

The Affiliated Hospital of Xuzhou Medical University

liusu_xzmu@163.com+86 181 1830 9692

Outcome results

None listed

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