Drug EffectPhase 2NCT05975255
Dose Finding Study for Remimazolam in Children
A Phase 2 study testing Remimazolam besylate in people with Drug Effect, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- Remimazolam besylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2023to 31 Dec 2024
- Phase
- Phase 2
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled to undergo general anesthesia or sedation
- American Society of Anesthesiologist Physical Status of 1 or 2
Who cannot join
- Presence of Upper respiratory tract infection or any pulmonary disease
- Presence of subglottic stenosis, laryngomalacia, or tracheomalacia
- History of hypersensitivity to benzodiazepines or propofol
- History of hypersensitivity to beans or peanut
- History of seizure
- Presence of arrhythmia, tachycardia, or bradycardia
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- Presence of acute closed-angle glaucoma
- Patients with unstable vital sign
- Presence of sleep apnea
- Presence of galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
- History of hypersensitivity to dextran 40
- Refusal to enroll by one or more parents or legal guardian
- Other conditions the researchers regarded as inappropriate to enroll
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sang-Hwan Ji, M.D., M.S., +82-2-2072-3661, taepoongshin@gmail.com
About this study
Official title: Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study
This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.
Read the detailed description
We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.
When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.
We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.
- Conditions
- Drug Effect
- Being tested
- Remimazolam besylate
- Keywords
- Remimazolam, Children, Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Also called Byfavo
Intravenous administration of predetermined dose of Byfavo for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Remimazolam administration and evaluation of sedative effect Receives: Drug: Remimazolam besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of consciousness
Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate
Measured: From start of remimazolam administration to 2 minute after end of administration
Secondary outcomes (6)
UMSS (University of Michigan Sedation Scale)
Serial measurement of University of Michigan Sedation Scale
Measured: From start of remimazolam administration to 2 minute after end of administration
Heart rate
Serial measurement of heart rate
Measured: From start of remimazolam administration to 2 minute after end of administration
Pulse oximetry
Serial measurement of pulse oximetry
Measured: From start of remimazolam administration to 2 minute after end of administration
Noninvasive mean blood pressure
Serial measurement of noninvasive mean blood pressure
Measured: From start of remimazolam administration to 2 minute after end of administration
Anesthetic depth
Serial measurement of electroencephalogram-based anesthetic depth monitoring
Measured: From start of remimazolam administration to 2 minute after end of administration
Apnea
Incidence of apnea after administration of remimazolam besylate
Measured: From start of remimazolam administration to 2 minute after end of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start16 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug EffectStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential allocation to drug dosage according to result of previous participant
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975255
- Sponsor's protocol ID
- 2306-198-1445
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2023
- 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
Kilpatrick GJ, McIntyre MS, Cox RF, Stafford JA, Pacofsky GJ, Lovell GG, Wiard RP, Feldman PL, Collins H, Waszczak BL, Tilbrook GS. CNS 7056: a novel ultra-short-acting Benzodiazepine. Anesthesiology. 2007 Jul;107(1):60-6. doi: 10.1097/01.anes.0000267503.85085.c0.
PubMed 17585216Gorges M, Zhou G, Brant R, Ansermino JM. Sequential allocation trial design in anesthesia: an introduction to methods, modeling, and clinical applications. Paediatr Anaesth. 2017 Mar;27(3):240-247. doi: 10.1111/pan.13088. Epub 2017 Feb 17.
PubMed 28211193Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
PubMed 22190555
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
- Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study
- ClinicalTrials.gov ID
- NCT05975255
- Acronym / sponsor ID
- 2306-198-1445
- Conditions
- Drug Effect
- Keywords
- Remimazolam, Children, Dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.
Detailed description
We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.
When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.
We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential allocation to drug dosage according to result of previous participant
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Remimazolam besylateRemimazolam administration and evaluation of sedative effect |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children scheduled to undergo general anesthesia or sedation
- American Society of Anesthesiologist Physical Status of 1 or 2
Key exclusion criteria (13 listed)
- Presence of Upper respiratory tract infection or any pulmonary disease
- Presence of subglottic stenosis, laryngomalacia, or tracheomalacia
- History of hypersensitivity to benzodiazepines or propofol
- History of hypersensitivity to beans or peanut
- History of seizure
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 besylateAlso: ByfavoIntravenous administration of predetermined dose of Byfavo for 30 seconds | Drug | Study group |
Primary outcome
Loss of consciousness
Time frame: From start of remimazolam administration to 2 minute after end of administration
Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate
6 secondary outcomes
UMSS (University of Michigan Sedation Scale)
Time frame: From start of remimazolam administration to 2 minute after end of administration
Heart rate
Time frame: From start of remimazolam administration to 2 minute after end of administration
Pulse oximetry
Time frame: From start of remimazolam administration to 2 minute after end of administration
Noninvasive mean blood pressure
Time frame: From start of remimazolam administration to 2 minute after end of administration
Anesthetic depth
Time frame: From start of remimazolam administration to 2 minute after end of administration
Apnea
Time frame: From start of remimazolam administration to 2 minute after end of administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 17585216Kilpatrick GJ, McIntyre MS, Cox RF, Stafford JA, Pacofsky GJ, Lovell GG, Wiard RP, Feldman PL, Collins H, Waszczak BL, Tilbrook GS. CNS 7056: a novel ultra-short-acting Benzodiazepine. Anesthesiology. 2007 Jul;107(1):60-6. doi: 10.1097/01.anes.0000267503.85085.c0.
- Background: PubMed 28211193Gorges M, Zhou G, Brant R, Ansermino JM. Sequential allocation trial design in anesthesia: an introduction to methods, modeling, and clinical applications. Paediatr Anaesth. 2017 Mar;27(3):240-247. doi: 10.1111/pan.13088. Epub 2017 Feb 17.
- Background: PubMed 22190555Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
- 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.
Jin-Tae Kim, M.D., Ph.D. 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 Phase 2 study testing Remimazolam besylate in people with Drug Effect, 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 2 inclusion and 13 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sang-Hwan Ji, M.D., Ph.D. (82-2-2072-3661, jsh1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of consciousness (time frame: From start of remimazolam administration to 2 minute after end of administration). 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 NCT05975255, which also lists 3 linked publications.
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.