NCT05975255

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

July 27, 2023

Last Update Submit

November 20, 2023

Conditions

Drug Effect

Keywords

RemimazolamChildrenDose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • UMSS (University of Michigan Sedation Scale)

    From start of remimazolam administration to 2 minute after end of administration

  • Heart rate

    From start of remimazolam administration to 2 minute after end of administration

  • Pulse oximetry

    From start of remimazolam administration to 2 minute after end of administration

  • Noninvasive mean blood pressure

    From start of remimazolam administration to 2 minute after end of administration

  • Anesthetic depth

    From start of remimazolam administration to 2 minute after end of administration

  • +1 more secondary outcomes

Study Arms (1)

Study group

EXPERIMENTAL

Remimazolam administration and evaluation of sedative effect

Drug: Remimazolam besylate

Interventions

Remimazolam besylateDRUG

Intravenous administration of predetermined dose of Byfavo for 30 seconds

Also known as: Byfavo
Study group

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children scheduled to undergo general anesthesia or sedation
  • American Society of Anesthesiologist Physical Status of 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17585216BACKGROUND

  • 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.

    PMID: 28211193BACKGROUND

  • 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.

    PMID: 22190555BACKGROUND

Study Officials

  • Jin-Tae Kim, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hwan Ji, M.D., Ph.D.

CONTACT

82-2-2072-3661jsh1@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Sequential allocation to drug dosage according to result of previous participant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 3, 2023

Study Start

November 16, 2023

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)