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Effect of remimazolam tosylate vs sevoflurane on incidence of postoperative delirium in older patients undergoing hip arthroplasty: a multicenter randomized controlled clinical trial

Effect of remimazolam tosylate vs sevoflurane on incidence of postoperative delirium in older patients undergoing hip arthroplasty: a multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062455
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
Completion date
Unknown
Last updated
2023-04-12

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:Remimazolam

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing hip arthroplasty under general anesthesia with laryngeal mask airway; 2. Patients with American Society of Anesthesiologists (ASA) physical status I-II; 3. Patients aged 65 or older; 4. Patients who agree to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients without good cognitive function(MMSE score 23 or less) and language skills or with a history of neurological, psychiatric or epileptic diseases before surgery; 2. Patients with serious cardiovascular and cerebrovascular diseases, uncontrolled diabetes, and liver and kidney dysfunction; 3. Patients allergic to study drugs; 4. Patients who have received analgesic drugs or have a history of treatment; 5. Patients who refused to receive PCIA pump treatment after surgery; 6. Patients participating in other clinical trials; 7. Patients with difficult postoperative follow-up or poor compliance.

Design outcomes

Primary

MeasureTime frame
3D-Confusion Assessment Method (CAM), Chinese Version;

Secondary

MeasureTime frame
Visual analog scale, VAS;Awakening time;Incidence of postoperative nausea and vomiting;Mini-mental State Examination, MMSE;Use of vasoactive drugs;Hemoglobin;

Countries

China

Contacts

Public ContactDong-Liang Li

Qilu Hospital of Shandong University

ldl@sdu.edu.cn+86 15966056656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026