Dose Finding Study for Remimazolam in Children

Drug Effect Clinical Trial

Official title:

Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975255
• Other study ID #: 2306-198-1445
• Status: Recruiting
• Phase: Phase 2
• Start date: November 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Sang-Hwan Ji, M.D., Ph.D.
• Phone: 82-2-2072-3661
• Email: jsh1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children scheduled to undergo general anesthesia or sedation

• American Society of Anesthesiologist Physical Status of 1 or 2

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• Remimazolam besylate
Intravenous administration of predetermined dose of Byfavo for 30 seconds

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of consciousness	Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate	From start of remimazolam administration to 2 minute after end of administration
Secondary	UMSS (University of Michigan Sedation Scale)	Serial measurement of University of Michigan Sedation Scale	From start of remimazolam administration to 2 minute after end of administration
Secondary	Heart rate	Serial measurement of heart rate	From start of remimazolam administration to 2 minute after end of administration
Secondary	Pulse oximetry	Serial measurement of pulse oximetry	From start of remimazolam administration to 2 minute after end of administration
Secondary	Noninvasive mean blood pressure	Serial measurement of noninvasive mean blood pressure	From start of remimazolam administration to 2 minute after end of administration
Secondary	Anesthetic depth	Serial measurement of electroencephalogram-based anesthetic depth monitoring	From start of remimazolam administration to 2 minute after end of administration
Secondary	Apnea	Incidence of apnea after administration of remimazolam besylate	From start of remimazolam administration to 2 minute after end of administration