Safety and Efficacy of Remimazolam in OPCAB Surgery
- Conditions
- Coronary Artery Bypass Surgery
- Interventions
- Registration Number
- NCT05396690
- Lead Sponsor
- Ajou University School of Medicine
- Brief Summary
Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven.
In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured.
Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 94
- Adult patients 19 years of age or older to receive OPCAB surgery
- Clinical diagnosis of coronary artery obstructive disease
- Ejection fraction < 35% at preoperative ECHO test
- Mitral regurgitation > grade 2 at preoperative ECHO test
- Currently using inotropics
- Currently receiving mechanical support
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sevoflurane group Sevoflurane After injection of 2-5 mg of midazolam and 0.5-1.0 mcg/kg of sufentanil as an induction dose, 1 mg/kg of rocumerone is given intravenously when consciousness is lost, and endotracheal intubation is performed when sufficient muscle relaxation is achieved 2 minutes later. For maintenance of anesthesia, the concentration of sevoflurane and sufentanil effect site concentration is 0.4 to 0.5 to reach the appropriate depth of anesthesia, and the optimal degree of anesthesia is based on maintaining the BIS 35 to 65. remimazolam group Remimazolam Injection [Byfavo] In the Remimazolam group as an induction dose 6 mg/kg/h of remimazolam with 0.5-1.0 mcg/kg of sufentanil was injected together. If consciousness was lost, rocumerone 1 mg/kg was given intravenously, and endotracheal intubation was performed when sufficient muscle relaxation was achieved 2 minutes later. Maintenance of anesthesia is achieved by using a programmed infusion pump with remimazolam 1 mg/kg/h (up to 2 mg/kg/h) and sufentanil effect site concentration of 0.4 to 0.5 to reach the appropriate depth of anesthesia. The optimal level of anesthesia is based on maintaining a bispectral index (BIS) of 35-65.
- Primary Outcome Measures
Name Time Method cardiac index (T4) 5 minutes before operation The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T5) 10 minutes after starting left internal mammary artery dissection The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T6) 10 minutes after starting left anterior descending coronary artery anastomosis The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T7) 10 minutes after starting Y-graft anastomosis of graft vessels The cardiac index (CI) at that time was measured and compared between the two groups.
- Secondary Outcome Measures
Name Time Method NE dose During surgery(from induction of anesthesia to end of surgery) total amount of norepinephrine during OPCAB
Incidence of hypotension During surgery(from induction of anesthesia to end of surgery) The incidence of hypotension during OPCAB are counted by number which based on the anesthetic record.
Trial Locations
- Locations (1)
Ajou University Hospital
🇰🇷Suwon, Gyeonggido, Korea, Republic of