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Efficacy and Safety of Remimazolam Tosilate for Anesthesia Induction and Maintenance in Patient Undergoing Off-Pump Coronary Artery Bypass Grafting

Effect of Remimazolam Tosilate for Anesthesia Induction and Maintenance in Patient Undergoing Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Non-inferiority Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079615
Enrollment
Unknown
Registered
2024-01-08
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

coronary artery disease (CAD)

Interventions

Group R:Induction of anesthesia: 0.2mg /kg remimazolam tosilate + 1.0µg /kg sufentanil, BIS=70, intravenous injection of rocuronium 0.6-1.0mg /kg. 5 minutes after induction, if BIS=60, endotracheal in
If BIS is still > 60, add remimazolam 0.05 mg/kg per time, evaluate BIS again 2 minutes later, and add more if necessary. Anesthesia maintenance: remimazolam 0.2-2.0 mg/kg/h, Sufentanil 0.6 µg/kg/h,
Group E:Induction of anesthesia: 0.3mg /kg etomidate + 1.0µg /kg sufentanil, BIS=70, intravenous injection of rocuronium 0.6-1.0mg /kg. 5 minutes after induction, if BIS=60, endotracheal intubation wi
If BIS is still > 60, add etomidate 0.05 mg/kg per time, evaluate BIS again 2 minutes later, and add more if necessary. Anesthesia maintenance: propofol 4-10 mg/kg/h, Sufentanil 0.6 µg/kg/h, rocuroni

Sponsors

Zibo Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing scheduled off-pump coronary artery bypass grafting; 2. Aged 18-75 years old; 3. American Society of Anesthesiologists physical status ?-?; 4. Body Mass Index 18-30kg/m2; 5. Written informed consent form received from the patient or patient's legal representative.

Exclusion criteria

Exclusion criteria: 1. Severe arrhythmia, including severe sinus bradycardia (heart rate=50 beats per minutes), atrial fibrillation, third-degree atrioventricular block, frequent atrial premature beats, frequent ventricular premature beats. 2. Uncontrolled or poorly controlled hypertension (SBP=180mmHg and/or DBP=110 mmHg). 3. Abnormal liver or kidney dysfunction (Child-Pugh class B or C, BUN exceed 1.5 times of the upper limit of medical reference value and/or creatinine exceeds the upper limit of medical reference value. 4. Adrenal cortical dysfunction (serum cortisol <3µg/dL); 5. Allergy to the investigational drugs, such as remimazolam tosilate, etomidate, rocuronium. 6. Taking sedatives, hypnotics, antidepressants. 7. History of drug abuse, alcoholism; 8. Myasthenia gravis; 9. Patients with schizophrenia, severe depression, cognitive impairment, inability to communicate. 10. Other patients deemed unsuitable for inclusion by the investigators.

Design outcomes

Primary

MeasureTime frame
fluctuation of mean artery pressure during induction period, ?MAP;

Secondary

MeasureTime frame
AEs (hypotension, hypertension, tachycardia, bradycardia);Total dosage of vasoactive drugs in anesthesia induction and maintenance;

Countries

China

Contacts

Public ContactJiguo Si

Zibo Central Hospital

43254465@qq.com+86 186 7818 6929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026