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Feasibility Study of the Use of Remimazolam Tosylate During Cardiopulmonary Bypass

Feasibility Study of the Use of Remimazolam Tosylate During Cardiopulmonary Bypass

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109967
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Open-heart surgery under general anesthesia with cardiopulmonary bypass (including coronary artery bypass grafting, valve replacement, aortic replacement, etc.)

Interventions

Trial group:Intravenous infusion of remazolam during extracorporeal circulation
Control group:Intravenous propofol infusion during extracorporeal circulation

Sponsors

WeiHai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–80 years, undergoing cardiac surgery with cardiopulmonary bypass (CPB); 2.ASA Classification: Grade II-IV; 3.BMI range: 18.5-30 kg/m^2; 4.Patients participate voluntarily and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Preoperative heart failure, cardiogenic shock; 2.Preoperative long-term use of analgesic and/or psychotropic drugs; 3.Allergy to anesthesia drugs; 4.Chronic renal failure requiring dialysis; 5.Patients with severe pulmonary insufficiency; 6.Severe liver and kidney function disease; 7.Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
High-sensitivity cardiac troponin T (hs-cTnT);Blood lactate level;

Secondary

MeasureTime frame
Oxygenation Index;Incidence of adverse events during the perioperative period and within 3 months postoperatively (including sudden death, myocardial infarction, cerebral infarction, acute kidney injury, acute respiratory failure, acute liver failure, etc.).;Urine output;Cerebral oxygen saturation;Glasgow Coma Scale;Alanine aminotransferase / Aspartate aminotransferase;Blood creatinine level;

Countries

China

Contacts

Public ContactGao Haolei

WeiHai Municipal Hospital

17562606696@163.com+86 17562606696

Outcome results

None listed

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