AdultPhase 4NCT05423080
Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam
A Phase 4 study testing Bolus injection of remimazolam and Infusion of remimazolam in people with Adult and Anesthesia, General, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult, Anesthesia, General
- What is being tested?
- Bolus injection of remimazolam and Infusion of remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2022to 25 Nov 2022
- Phase
- Phase 4
- 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
- Adults 19 years of age or older undergoing surgery under general anesthesia
- ASA I-III
Who cannot join
- Intraoperative regional blocks (e.g. spinal anesthesia, epidural anesthesia, peripheral nerve block)
- Liver resection or liver transplantation
- Cardiopulmonary bypass
- Uncontrolled HTN (SBP ≧180 mmHg, or ≧160 in patients taking antihypertensive drugs)
- Uncontrolled DM (HbA1c antihypertensive drugs ≧9.0%)
- Total bilirubin ≧3.0 mg/ml or AST or ALS ≧2.5 times the upper limit of normal
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- Serum creatinine ≧2.0 mg/ml or ESRD on dialysis
- COPD in need of treatment
- Patients who are expected to have difficulty in tracheal extubation immediately after surgery for postoperative lung management
- Resistance to benzodiazepines
- Hypersensitivity to benzodiazepines, remifentanil, fentanyl citrate, rocuronium, sugammadex, flumazenil, or other anesthetic drugs
- Myasthenia gravis or myasthenic syndrome
- Myocardial infarction, transient ischemic attack, stroke, newly diagnosed coronary artery disease, percutaneous coronary intervention, or coronary artery bypass graft within 6 months
- Implantation of rate-responsive cardiac pacemaker with bioelectrical impedance sensor
- Organic brain disorder, or other neurologic diseases that cannot adequately measure EEG (BIS)
- Severe allergic diseases
- Cognitive impairment that makes it impossible to understand the instructions and informed consent of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Anesthetic Induction Time and Change of Bispectral Index Between Intravenous Bolus Administration and Continuous Infusion of Remimazolam for Anesthetic Induction: a Prospective Randomized Single-blind Study
Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.
In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)
- Conditions
- Adult, Anesthesia, General
- Being tested
- Bolus injection of remimazolam, Infusion of remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus injection of remimazolamDrug
Also called Bolus injection of Byfavo
Participants in this group are administered 0.2 mg/kg remimazolam via the bolus injection method for 20 seconds during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will administer additional doses of 0.05 mg/kg repeatedly until LOC occurs.
Infusion of remimazolamDrug
Also called Continuous infusion of Byfavo
Participants in this group are administered remimazolam at a rate of 6 mg/kg/hr via the continuous infusion method during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will escalate infusion dose to 12 mg/kg/hr until LOC occurs.
| Study group | Role | What they receive |
|---|---|---|
| Bolus group | Experimental | Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction. Receives: Drug: Bolus injection of remimazolam |
| Infusion group | Active comparator | Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction. Receives: Drug: Infusion of remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOAA/SS (sedation level)
The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups.
Measured: From initiation of remimazolam to LOC (up to 5 minutes)
Secondary outcomes (3)
Time from initiation of drug administration to bispectral index(BIS) <60
The investigators measure how long it takes from the start of remimazolam administration to reach BIS <60.
Measured: From initiation of remimazolam to BIS <60 (up to 10 minutes)
BIS
The investigators will measure BIS from the start of remimazolam administration to 15 minutes after surgical incision.
Measured: From initiation of remimazolam to 15 minutes after surgical incision
Hemodynamic stability (i.e. blood pressure, heart rate)
The investigators will evaluate hemodynamic stability from the start of remimazolam administration to 15 minutes after surgical incision
Measured: From initiation of remimazolam to 15 minutes after surgical incision
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 start3 Aug 2022
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Responsible party
- Principal investigator, Byung Gun Lim, Korea University Guro Hospital
- Investigators
- Byung Gun Lim, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423080
- Sponsor's protocol ID
- 2022GR0114
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic Induction Time and Change of Bispectral Index Between Intravenous Bolus Administration and Continuous Infusion of Remimazolam for Anesthetic Induction: a Prospective Randomized Single-blind Study
- ClinicalTrials.gov ID
- NCT05423080
- Acronym / sponsor ID
- 2022GR0114
- Conditions
- Adult, Anesthesia, General
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (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.
Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.
In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus group | Experimental | Drug: Bolus injection of remimazolamParticipants in this group are administered remimazolam via the bolus injection method during anesthesia induction. |
| Infusion group | Active comparator | Drug: Infusion of remimazolamParticipants in this group are administered remimazolam via the continuous infusion method during anesthesia induction. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 19 years of age or older undergoing surgery under general anesthesia
- ASA I-III
Key exclusion criteria (17 listed)
- Intraoperative regional blocks (e.g. spinal anesthesia, epidural anesthesia, peripheral nerve block)
- Liver resection or liver transplantation
- Cardiopulmonary bypass
- Uncontrolled HTN (SBP ≧180 mmHg, or ≧160 in patients taking antihypertensive drugs)
- Uncontrolled DM (HbA1c antihypertensive drugs ≧9.0%)
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 |
|---|---|---|
| Bolus injection of remimazolamAlso: Bolus injection of ByfavoParticipants in this group are administered 0.2 mg/kg remimazolam via the bolus injection method for 20 seconds during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will administer additional doses of 0.05 mg/kg repeatedly until LOC occurs. | Drug | Bolus group |
| Infusion of remimazolamAlso: Continuous infusion of ByfavoParticipants in this group are administered remimazolam at a rate of 6 mg/kg/hr via the continuous infusion method during anesthesia induction. If loss of consciousness (LOC) does not occur, the investigators will escalate infusion dose to 12 mg/kg/hr until LOC occurs. | Drug | Infusion group |
Primary outcome
MOAA/SS (sedation level)
Time frame: From initiation of remimazolam to LOC (up to 5 minutes)
The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups.
3 secondary outcomes
Time from initiation of drug administration to bispectral index(BIS) <60
Time frame: From initiation of remimazolam to BIS <60 (up to 10 minutes)
BIS
Time frame: From initiation of remimazolam to 15 minutes after surgical incision
Hemodynamic stability (i.e. blood pressure, heart rate)
Time frame: From initiation of remimazolam to 15 minutes after surgical incision
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 9 Dec 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.
Byung Gun Lim, MD, PhD principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bolus injection of remimazolam and Infusion of remimazolam in people with Adult and Anesthesia, General, run by Korea University Guro 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 2 inclusion and 17 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 9 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MOAA/SS (sedation level) (time frame: From initiation of remimazolam to LOC (up to 5 minutes)). 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 9 Dec 2022.