Skip to content

The efficacy and safety of remimazolam versus propofol in frail stratified elderly surgical patients: A prospective, multicenter, randomized, open-label, practical non-inferiority clinical trial

The efficacy and safety of remimazolam versus propofol in frail stratified elderly surgical patients: A prospective, multicenter, randomized, open-label, practical non-inferiority clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113942
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-05
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None

Interventions

Remimazolam group:Remimazolam
Propofol group:Propofol

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age = 60 years, regardless of gender; 2.Patients scheduled to undergo non-cardiovascular surgery (elective/emergency) under general anesthesia, with an operation time > 0.5 hours and = 4 hours; 3.ASA classification grades I to III; 4.Conforming to ethics, without dementia, and the patients voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Any cerebrovascular accident occurring within 3 months, such as stroke, transient ischemic attack (TIA), etc. 2.Those who have experienced unstable angina pectoris or myocardial infarction within 3 months; 3.Severe valvular heart disease, atrial fibrillation, frequent atrial premature beats or ventricular premature beats, congestive heart failure, etc.; 4.Preoperative visit blood pressure = 180/110 mm Hg (grade 3 hypertension according to the WHO-ISH hypertension guidelines); 5.Those with confirmed or suspected abuse of or long-term use of narcotic sedative analgesics; 6.Those with a history of asthma; 7.Patients with a preoperative MMSE score of < 18 points; 8.Perioperative sudden severe complications; 9.Termination of the clinical protocol for any reason or withdrawal at the patient's request;

Design outcomes

Primary

MeasureTime frame
Incidence of In-Hospital Postoperative Complications;

Secondary

MeasureTime frame
Hemodynamic stability during anesthesia;

Countries

China

Contacts

Public ContactWang Yong

The First Affiliated Hospital of Zhengzhou University

wangyong2009999@163.com+86 150 3802 0177

Outcome results

None listed

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