NCT05990673

Brief Summary

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

August 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 7, 2023

Last Update Submit

August 7, 2023

Conditions

Anesthesia

Keywords

general anesthesiaanesthesia inductionremimazolam

Outcome Measures

Primary Outcomes (1)

  • half effective dosage

    the dosage by which half of the patients will be sedated

    from injection of remimazolam to loss of consciousness, at an average of 5 minutes

Secondary Outcomes (1)

  • 95% effective dosage

    from injection of remimazolam to loss of consciousness, at an average of 5 minutes

Study Arms (1)

remimazolam

EXPERIMENTAL

remimazolam is given for anesthesia induction

Drug: Remimazolam

Interventions

RemimazolamDRUG

remimazolam is given intravenously

Also known as: remimazolam besylate
remimazolam

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age from 3 to 12 years old
  • patients scheduled for surgery under general anesthesia

You may not qualify if:

  • American Society of Anesthesiologists status \>=Ⅲ
  • Body mass index\>=28kg/m2
  • patients who cannot cooperate with intravenous anesthesia induction
  • patients with risk of difficult airway
  • patients who are allergic to benzodiazepines
  • patients with delayed neurologic function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.

    PMID: 37333966RESULT

MeSH Terms

Interventions

remimazolam

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 14, 2023

Study Start

August 10, 2023

Primary Completion

September 10, 2023

Study Completion

September 10, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08