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Effect of Remimazolam and Propofol on Postoperative Delirium in Preoperatively Frail Elderly Patients Undergoing Hip Surgery: A Prospective Randomized Controlled Clinical Trial

Effect of Remimazolam and Propofol on Postoperative Delirium in Preoperatively Frail Elderly Patients Undergoing Hip Surgery: A Prospective Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068632
Enrollment
Unknown
Registered
2023-02-26
Start date
2023-03-21
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Postoperative delirium

Interventions

R group:General anesthesia induction and anesthesia maintenance with remimazolam besylate
P group:General anesthesia induction and anesthesia maintenance with propofol

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=65 years; 2. ASA I-IV; 3. patients with a clinical or radiographic diagnosis of a hip fracture (including femoral neck, femoral head, intertrochanteric or subtrochanteric fracture) who are scheduled for elective surgical repair; 4. patients or their principals agree to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients involved in multiple injuries or multiple fractures; 2. Patients with relative contraindications to general anesthesia; 3. Patients with visual, speech, or hearing impairments, neuropsychiatric disorders (including conditions such as dementia that prevent them from cooperating with the evaluation or participating in the trial); 4. Patients with an Edmonton Frailty Reporting Scale (REFS) score of 0-5; 5. Patients who have been enrolled in other clinical studies in the last 3 months; 6. Patients who are considered unsuitable for randomization grouping from health considerations.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium;

Secondary

MeasureTime frame
Quality of post-operative recovery;Postoperative complications;Length of hospital-stay;Intraoperative vital signs/EEG and other indicators;Recovery quality;

Countries

China

Contacts

Public ContactJie Sun

Zhongda Hospital Southeast University

dgsunjie@hotmail.com+86 158 9597 1012

Outcome results

None listed

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