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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 parallel-arm, randomized controlled, non-inferiority trial.

Effects of dexmedetomidine nasal spray on the eve of surgery on postoperative delirium in elderly patients undergoing knee/hip arthroplasty: a parallel-arm, randomized controlled, non-inferiority trial.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095511
Enrollment
Unknown
Registered
2025-01-08
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

knee/hip arthroplasty, postoperative delirium

Interventions

experimental group:Before the patient fell asleep the night before the operation, dexmedetomidine will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on eac
10 minutes before induction, 0.3ml/kg of normal saline will be pumped intravenously.
control group:Before the patient fell asleep the night before the operation, normal saline will be sprayed into the nasal cavity, 1 spray on each nostril stayed for 30s, and then 1 spray on each nostr
10 minutes before induction, 0.6µg/kg of dexmedetomidine will be pumped intravenously (dilute dexmedetomidine injection to 2 µg/ml).

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. Other contraindications to the use of dexmedetomidine.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 3 days after surgery;

Secondary

MeasureTime frame
Duration and severity of delirium;Perioperative 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;Time to first ambulation postoperatively;Quality of recovery postoperatively;Incidence of delirium within 7 days after surgery;The incidence of Tachycardia;The incidence of hypotension;The incidence of hyertension;Incidence of hypoxemia;Incidence of nasal mucosal injury caused by nasal spray;The incidence of bradycardia;

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