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Effect Of Remimazolam Tosylate Versus Propofol On Postoperative Delirium In Preoperatively Frail Elderly Patients Undergoing Hip Surgery: A Multicenter Randomised Controlled Trial

Effect Of Remimazolam Tosylate Versus Propofol On Postoperative Delirium In Preoperatively Frail Elderly Patients Undergoing Hip Surgery: A Multicenter Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116231
Enrollment
Unknown
Registered
2026-01-07
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Postoperative Delirium

Interventions

Group Remimazolam:Total intravenous anesthesia with remimazolam

Sponsors

zhongda hospital southeast university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with hip fracture and scheduled for elective repair surgery under general anesthesia; 2. Aged >= 65 years, regardless of gender; 3. ASA physical status I–III; 4. Frailty determined by preoperative screening (self-reported Edmonton Frailty Scale [REFS] score >= 6 points); 5. Patient or their authorized representative agrees to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with multiple injuries or fractures; 2.Patients with relative contraindications to general anesthesia (such as malignant hyperthermia); 3.Patients with visual, speech, or hearing impairments, or neuropsychiatric disorders (including those unable to cooperate with assessments or with impaired baseline MMSE scores); 4.Patients who have participated in other clinical studies within the past three months; 5.Patients deemed unsuitable for randomization by the anesthesiologist and surgeon for health reasons.

Design outcomes

Primary

MeasureTime frame
The incidence of delirium within 3 days after surgery;

Secondary

MeasureTime frame
The incidence of delirium within 7 days after surgery(or prior to discharge);Burst suppression time and its proportion relative to the total surgery time;Preoperative and postoperative levels of the inflammatory cytokine and S-100ß protein;Emergence Delirium;Adverse events in the PACU;The Burden of Postoperative Delirium;Hypotension after anesthesia induction;Daily NRS score;Incidence of postoperative complications;Hemodynamic fluctuations;One-Month Postoperative Cognitive Follow-Up;Postoperative delirium subtypes, onset time, duration, frequency, and severity;Intraoperative awareness;Unplanned ICU admission;

Countries

China

Contacts

Public ContactSun Jie

zhongda hospital southeast university

dgsunjie@hotmail.com+86 25 8272064

Outcome results

None listed

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