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The Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery

The Effect of Remimazolam on Perioperative Cognitive Function in Elderly Patients Undergoing Orthopedic Surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105688
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-08-10
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Postoperative Delirium

Interventions

Remimazolam Group (R group):In the Remimazolam group (R group), anesthesia induction was performed with intravenous administration of remimazolam at 0.3 mg/kg, sufentanil at 0.3 µg/kg, and rocuronium
Propofol Group (P group):In the Propofol group (P group), anesthesia induction was performed with intravenous injection of propofol at 1–2 mg/kg, sufentanil at 0.3 µg/kg, and rocuronium at 0.6 mg/kg.

Sponsors

Shanxi Jincheng General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years, no restriction on gender; 2.Scheduled to undergo orthopedic surgery; 3.Classified as ASA physical status I–III; 4.Preoperative Mini-Mental State Examination (MMSE) score >= 21, with no evidence of significant cognitive impairment; 5.Signed informed consent obtained, with full understanding of and compliance with the study requirements.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to remimazolam; 2. Those who need ICU management or indwelling tracheal intubation after surgery; 3. BMI>35 kg/m^2 or severe cardiopulmonary disease, liver and kidney insufficiency; 4. Presence of central nervous system disease (infectious, metabolic, degenerative, neoplastic) or severe mental disorder; 5. Have a history or current presence of delirium; 6. Severe visual or hearing impairment; 7. Dependence on alcohol or other drugs; 8. Long-term or recent use of benzodiazepines, antidepressants, or antipsychotics; 9. Active symptomatic infection or systemic inflammation (elevated leukocytes or elevated C-reactive protein).

Design outcomes

Primary

MeasureTime frame
Postoperative Delirium;

Secondary

MeasureTime frame
Emergence Quality;Postoperative Sleep Quality;Postoperative Pain Score;

Countries

China

Contacts

Public ContactFan Wei

Shanxi Jincheng General Hospital

fanwei108315@163.com+86 158 3562 8896

Outcome results

None listed

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