Hemodynamic InstabilityNCT05423951
Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients
A study testing REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Propofol and Rocuronium in people with Hemodynamic Instability, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Propofol and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2022to 8 Nov 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 patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting
Who cannot join
- Patients who refuse to participate
- Concomitant heart valve surgery or thoracic aorta surgery
- Emergent surgery
- Preoperative sedation
- Intubated state
- Patients with mechanical circulatory assist device
Show all 11Show fewer
- Preoperative use of inotropes or vasopressors
- History of allergy or adverse reaction to study drugs
- Rapid sequence intubation
- Lactose intolerance
- Peanut allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting
Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.
- Conditions
- Hemodynamic Instability
- Being tested
- REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Propofol, Rocuronium, Sufentanil
- Keywords
- hemodynamics, remimazolam, propofol, coronary artery bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]Drug
Also called Remimazolam Besylate
For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.
PropofolDrug
For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.
RocuroniumDrug
After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed
SufentanilDrug
During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Not described Receives: Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]; Drug: Rocuronium; Drug: Sufentanil |
| Propofol | Active comparator | Not described Receives: Drug: Propofol; Drug: Rocuronium; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP-time integral
The area under the baseline MAP (sec * mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.
Measured: During 10 minute from the administration of the study drug
Secondary outcomes (13)
Time to loss of consciousness
The time from the study drug administration to loss of consciousness
Measured: During 10 minute from the administration of the study drug
Mean blood pressure
maximum / minimum value (mmHg)
Measured: During 10 minute from the administration of the study drug
Heart rate
maximum / minimum / mean / median / time-weighted average values (bpm)
Measured: During 10 minute from the administration of remimazolam or propofol
Regional cerebral oxygen saturation
continuous monitoring of regional cerebral oxygen saturation during surgery (%)
Measured: During 10 minute from the administration of the study drug
Cardiac output
continuous monitoring of cardiac output (L/min)
Measured: During 10 minute from the administration of the study drug
Sufentanil dose
Total dose of administered sufentanil (mcg)
Measured: During 10 minute from the administration of the study drug
Crystalloid
Total volume of administered crystalloid (ml)
Measured: During 10 minute from the administration of the study drug
Study drug dose
Total dose of administered remimazolam or propofol (mg)
Measured: During 10 minute from the administration of the study drug
Number of vasopressor administration
- Total number (n)
- Ephedrine (n)
- Phenylephrine (n)
- Vasopressin (n)
- Norepinephrine (n)
Measured: During 10 minute from the administration of the study drug
Ephedrine dose
Total dose of administered ephedrine (mg)
Measured: During 10 minute from the administration of the study drug
Phenylephrine dose
Total dose of administered phenylephrine (mcg)
Measured: During 10 minute from the administration of the study drug
Vasopressin dose
Total dose of administered vasopressin (unit) 2. Ephedrine: total dose / number of administration 3. Phenylephrine: total dose / number of administration 4. Vasopressin: total dose / number of administration 5. Norepinephrine: total dose / number of administration
Measured: During 10 minute from the administration of the study drug
Norepinephrine dose
Total dose of administered norepinephrine (mcg)
Measured: During 10 minute from the administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start26 Jul 2022
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423951
- Sponsor's protocol ID
- Remimazolam_OPCAB
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ju JW, Lee DJ, Chung J, Lee S, Cho YJ, Jeon Y, Nam K. Effect of remimazolam versus propofol on hypotension after anesthetic induction in patients undergoing coronary artery bypass grafting: A randomized controlled trial. J Clin Anesth. 2024 Nov;98:111580. doi: 10.1016/j.jclinane.2024.111580. Epub 2024 Aug 9.
PubMed 39126872
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05423951
- Acronym / sponsor ID
- Remimazolam_OPCAB
- Conditions
- Hemodynamic Instability
- Keywords
- hemodynamics, remimazolam, propofol, coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 21 Jun 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 ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Drug: Rocuronium, Drug: Sufentanil |
| Propofol | Active comparator | Drug: Propofol, Drug: Rocuronium, Drug: Sufentanil |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting
Key exclusion criteria (11 listed)
- Patients who refuse to participate
- Concomitant heart valve surgery or thoracic aorta surgery
- Emergent surgery
- Preoperative sedation
- Intubated state
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 BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]Also: Remimazolam BesylateFor the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60. | Drug | Remimazolam |
| PropofolFor the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60. | Drug | Propofol |
| RocuroniumAfter the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed | Drug | Propofol, Remimazolam |
| SufentanilDuring the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion. | Drug | Propofol, Remimazolam |
Primary outcome
MAP-time integral
Time frame: During 10 minute from the administration of the study drug
The area under the baseline MAP (sec * mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.
13 secondary outcomes
Time to loss of consciousness
Time frame: During 10 minute from the administration of the study drug
Mean blood pressure
Time frame: During 10 minute from the administration of the study drug
Heart rate
Time frame: During 10 minute from the administration of remimazolam or propofol
Regional cerebral oxygen saturation
Time frame: During 10 minute from the administration of the study drug
Cardiac output
Time frame: During 10 minute from the administration of the study drug
Sufentanil dose
Time frame: During 10 minute from the administration of the study drug
Crystalloid
Time frame: During 10 minute from the administration of the study drug
Study drug dose
Time frame: During 10 minute from the administration of the study drug
Number of vasopressor administration
Time frame: During 10 minute from the administration of the study drug
Ephedrine dose
Time frame: During 10 minute from the administration of the study drug
Phenylephrine dose
Time frame: During 10 minute from the administration of the study drug
Vasopressin dose
Time frame: During 10 minute from the administration of the study drug
Norepinephrine dose
Time frame: During 10 minute from the administration of the study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 39126872Ju JW, Lee DJ, Chung J, Lee S, Cho YJ, Jeon Y, Nam K. Effect of remimazolam versus propofol on hypotension after anesthetic induction in patients undergoing coronary artery bypass grafting: A randomized controlled trial. J Clin Anesth. 2024 Nov;98:111580. doi: 10.1016/j.jclinane.2024.111580. Epub 2024 Aug 9.
- Individual participant dataSharing planned: No
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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.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
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 BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO], Propofol and Rocuronium in people with Hemodynamic Instability, run by Seoul National University Hospital 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 22 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP-time integral (time frame: During 10 minute from the administration of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423951, which also lists 1 linked publication.
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 22 Nov 2023.