Anesthesia
Conditions
Brief summary
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.
Detailed description
Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.
Interventions
DRUGremimazolam besylate
Patients 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.
DRUGpropofol
Patients 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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Elective cardiac surgery via cardiopulmonary bypass; 2. Aged 18-65 years; 3. American Society of Anesthesiologists (ASA) grade I-III; 4. Body mass index (BMI) 18-28 kg/m2.
Exclusion criteria
1. A history of sternotomy for heart disease; 2. Angina or arrhythmia with severe dynamics flutters pre-operation; 3. Respiratory, hepatic or renal dysfunction (oxygenation index\<300, alanine transaminase\> 2 upper limits of normal value, creatinine \> 200 μmol/L); 4. Diagnosed with advanced tumors; 5. Psychiatric or mental disorders; 6. Myasthenia gravis or seizures; 7. Pregnant or lactating females; 8. A history of benzodiazepines administration within 3 months before surgery; 9. Known allergic to benzodiazepines, opioids, propofol and flumazenil; 10. Involved in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ratio of successful sedation during the whole surgery | Intraoperative period | 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
| Measure | Time frame |
|---|---|
| time interval for BIS from baseline before induction to 60 | Intraoperative period |
Outcome results
None listed