Coronary Artery Bypass Surgery
Conditions
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.
Interventions
Induction dose: 6 mg/kg/h with sufentanil Maintenance dose: 1\ 2 mg/kg/h with sufentanil If arousal occurs during surgery, rapidly increase the infusion rate of remimazolam to 12 mg/kg/h and infuse for 1 minute. If the patient's arousal persists after these measures, stop remimazolam infusion and replace with another drug.
DRUGSevoflurane
Induction dose: 2\ 3 mg midazolam with sufentanil Maintenance: Adjust the concentration to be BIS 35-65 based on 0.5 mac If arousal occurs during surgery, raise the concentration of sevoflurane to 1.5 MAC (increase the total gas flow rate to 8 l/min) and if arousal persists after 1 minute, administer midazolam 2-3 mg.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 19 years of age or older to receive OPCAB surgery * Clinical diagnosis of coronary artery obstructive disease
Exclusion criteria
* Ejection fraction \< 35% at preoperative ECHO test * Mitral regurgitation \> grade 2 at preoperative ECHO test * Currently using inotropics * Currently receiving mechanical support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary Contactji young yoo
Outcome results
None listed