About this trial
The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective cardiac surgery via cardiopulmonary bypass;
Aged 18-65 years;
American Society of Anesthesiologists (ASA) grade I-III;
Body mass index (BMI) 18-28 kg/m2.
Disqualifiers
A history of sternotomy for heart disease;
Angina or arrhythmia with severe dynamics flutters pre-operation;
Respiratory, hepatic or renal dysfunction (oxygenation index<300, alanine transaminase> 2 upper limits of normal value, creatinine > 200 μmol/L);
Diagnosed with advanced tumors;
Trial design
Parallel
Treatments tested in this trial
remimazolam besylate
DrugPatients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.
propofol
DrugPatients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.
Treatment groups
Trial outcomes
Primary outcomes
ratio of successful sedation during the whole surgery
Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures.
Secondary outcomes
time interval for BIS from baseline before induction to 60
Locations
Sponsors and contacts
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