Coronary Artery Bypass SurgeryNCT05396690
Safety and Efficacy of Remimazolam in OPCAB Surgery
A study testing Remimazolam Injection [Byfavo] and Sevoflurane in people with Coronary Artery Bypass Surgery, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- Remimazolam Injection [Byfavo] and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 19 years of age or older to receive OPCAB surgery
- Clinical diagnosis of coronary artery obstructive disease
Who cannot join
- Ejection fraction < 35% at preoperative ECHO test
- Mitral regurgitation > grade 2 at preoperative ECHO test
- Currently using inotropics
- Currently receiving mechanical support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery
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.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- Remimazolam Injection [Byfavo], Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Injection [Byfavo]Drug
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.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam group | Experimental | 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. Receives: Drug: Remimazolam Injection [Byfavo] |
| sevoflurane group | Other | 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. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index (T4)
The cardiac index (CI) at that time was measured and compared between the two groups.
Measured: 5 minutes before operation
cardiac index (T5)
The cardiac index (CI) at that time was measured and compared between the two groups.
Measured: 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.
Measured: 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.
Measured: 10 minutes after starting Y-graft anastomosis of graft vessels
Secondary outcomes (2)
NE dose
total amount of norepinephrine during OPCAB
Measured: During surgery(from induction of anesthesia to end of surgery)
Incidence of hypotension
The incidence of hypotension during OPCAB are counted by number which based on the anesthetic record.
Measured: During surgery(from induction of anesthesia to end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396690
- Sponsor's protocol ID
- AJIRB-MED-INT-21-641
- Status last verified
- Jun 2022
- First submitted
- 15 Apr 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery
- ClinicalTrials.gov ID
- NCT05396690
- Acronym / sponsor ID
- AJIRB-MED-INT-21-641
- Conditions
- Coronary Artery Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam group | Experimental | Drug: 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. |
| sevoflurane group | Other | Drug: SevofluraneAfter 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 19 years of age or older to receive OPCAB surgery
- Clinical diagnosis of coronary artery obstructive disease
Key exclusion criteria (4 listed)
- Ejection fraction < 35% at preoperative ECHO test
- Mitral regurgitation > grade 2 at preoperative ECHO test
- Currently using inotropics
- Currently receiving mechanical support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam Injection [Byfavo]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. | Drug | remimazolam group |
| SevofluraneInduction 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. | Drug | sevoflurane group |
Primary outcome
cardiac index (T4)
Time frame: 5 minutes before operation
The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T5)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
NE dose
Time frame: During surgery(from induction of anesthesia to end of surgery)
Incidence of hypotension
Time frame: During surgery(from induction of anesthesia to end of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam Injection [Byfavo] and Sevoflurane in people with Coronary Artery Bypass Surgery, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ji young yoo (01056902104, anesyoo@aumc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac index (T4) (time frame: 5 minutes before operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.