Hypotension on InductionNCT05536323
Bolus Versus Continuous Remimazolam for Anesthetic Induction
A study testing Remimazolam bolus and Remimazolam continuous in people with Hypotension on Induction, run by Kangbuk Samsung Hospital.
Trial summary
Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- Remimazolam bolus and Remimazolam continuous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Dec 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
- scheduled for elective surgery under general anesthesia
- adult patient (over 19 years old)
- American Society of Anesthesiology Physical Status I-III
Who cannot join
- arrythmia
- liver dysfunction
- kidney dysfunction
- uncontrolled hypertension
- uncontrolled diabetes mellitus
- allergic to benzodiazepines
Show all 9Show fewer
- heart failure
- drug intoxication
- alcohol intoxication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.
This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.
- Conditions
- Hypotension on Induction
- Being tested
- Remimazolam bolus, Remimazolam continuous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam bolusDrug
Remimazolam bolus 0.14-0.33 mg/kg 0.25-0.33 mg/kg, <40 years 0.19-0.25 mg/kg, 60-80 years 0.14-0.19 mg/kg, >80 years
Remimazolam continuousDrug
Remimazolam 12 mg/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Bolus | Experimental | Anesthetic induction with bolus remimazolam administration Receives: Drug: Remimazolam bolus |
| Continuous | Experimental | Anesthetic induction with continuous remimazolam administration Receives: Drug: Remimazolam continuous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Systolic pressure below 90 mmHg
Measured: 10 minutes after anesthetic induction
Secondary outcomes (5)
Incidence of bradycardia
heart rate below 40 beats per minute
Measured: 10 minutes after anesthetic induction
The lowest systolic blood pressure
The lowest systolic blood pressure
Measured: 10 minutes after anesthetic induction
Number of participants with vasoactive drug use
Use of vasoactive drug for the blood pressure or the heart rate management
Measured: 10 minutes after anesthetic induction
Time to loss of consciousness
Time from drug administration to loss of consciousness
Measured: 10 minutes after anesthetic induction
Dosage of remimazolam
Total dose or remimazolam used for anesthetic induction
Measured: 10 minutes after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jul 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Cho E Ah, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536323
- Sponsor's protocol ID
- RMZ_bolcon
- Status last verified
- May 2023
- First submitted
- 5 Sep 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT05536323
- Acronym / sponsor ID
- RMZ_bolcon
- Conditions
- Hypotension on Induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 10 Sep 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 newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.
This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus | Experimental | Drug: Remimazolam bolusAnesthetic induction with bolus remimazolam administration |
| Continuous | Experimental | Drug: Remimazolam continuousAnesthetic induction with continuous remimazolam administration |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for elective surgery under general anesthesia
- adult patient (over 19 years old)
- American Society of Anesthesiology Physical Status I-III
Key exclusion criteria (9 listed)
- arrythmia
- liver dysfunction
- kidney dysfunction
- uncontrolled hypertension
- uncontrolled diabetes mellitus
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 bolusRemimazolam bolus 0.14-0.33 mg/kg 0.25-0.33 mg/kg, <40 years 0.19-0.25 mg/kg, 60-80 years 0.14-0.19 mg/kg, >80 years | Drug | Bolus |
| Remimazolam continuousRemimazolam 12 mg/kg/hr | Drug | Continuous |
Primary outcome
Incidence of hypotension
Time frame: 10 minutes after anesthetic induction
Systolic pressure below 90 mmHg
5 secondary outcomes
Incidence of bradycardia
Time frame: 10 minutes after anesthetic induction
The lowest systolic blood pressure
Time frame: 10 minutes after anesthetic induction
Number of participants with vasoactive drug use
Time frame: 10 minutes after anesthetic induction
Time to loss of consciousness
Time frame: 10 minutes after anesthetic induction
Dosage of remimazolam
Time frame: 10 minutes after anesthetic induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Cho E Ah principal investigator
Kangbuk Samsung Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam bolus and Remimazolam continuous in people with Hypotension on Induction, run by Kangbuk Samsung Hospital.
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 3 inclusion and 9 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Cho E Ah, PhD (82-2001-4657, eunahthereal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: 10 minutes after anesthetic induction). 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 2 Jun 2023.