Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2023-11-16
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Study group
Remimazolam administration and evaluation of sedative effect
Remimazolam besylate
Intravenous administration of predetermined dose of Byfavo for 30 seconds
Interventions
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Remimazolam besylate
Intravenous administration of predetermined dose of Byfavo for 30 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologist Physical Status of 1 or 2
Exclusion Criteria
* 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
* 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
2 Years
8 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Principal Investigators
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Jin-Tae Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Gorges 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.
Antonik 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.
Other Identifiers
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2306-198-1445
Identifier Type: -
Identifier Source: org_study_id