Safety and Efficacy of Remimazolam in OPCAB Surgery
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJune 15, 2022
June 1, 2022
12 months
April 15, 2022
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
cardiac index (T4)
The cardiac index (CI) at that time was measured and compared between the two groups.
5 minutes before operation
cardiac index (T5)
The cardiac index (CI) at that time was measured and compared between the two groups.
10 minutes after starting left internal mammary artery dissection
cardiac index (T6)
The cardiac index (CI) at that time was measured and compared between the two groups.
10 minutes after starting left anterior descending coronary artery anastomosis
cardiac index (T7)
The cardiac index (CI) at that time was measured and compared between the two groups.
10 minutes after starting Y-graft anastomosis of graft vessels
Secondary Outcomes (2)
NE dose
During surgery(from induction of anesthesia to end of surgery)
Incidence of hypotension
During surgery(from induction of anesthesia to end of surgery)
Study Arms (2)
remimazolam group
EXPERIMENTALIn 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.
sevoflurane group
OTHERAfter 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.
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.
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.
Eligibility Criteria
You may qualify if:
- Adult patients 19 years of age or older to receive OPCAB surgery
- Clinical diagnosis of coronary artery obstructive disease
You may not qualify if:
- Ejection fraction \< 35% at preoperative ECHO test
- Mitral regurgitation \> grade 2 at preoperative ECHO test
- Currently using inotropics
- Currently receiving mechanical support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou University Hospital
Suwon, Gyeonggido, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
April 15, 2022
First Posted
May 31, 2022
Study Start
June 15, 2022
Primary Completion
May 30, 2023
Study Completion
September 30, 2023
Last Updated
June 15, 2022
Record last verified: 2022-06