NCT06419543

Brief Summary

Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

May 13, 2024

Last Update Submit

October 26, 2024

Conditions

Endoscopy, Gastrointestinal

Outcome Measures

Primary Outcomes (1)

  • incidence of paradoxical reaction

    observe the incidence of paradoxical reaction within 2 minutes

    2 minutes after first infusion of remimazolam

Secondary Outcomes (4)

  • performance and duration of paradoxical reaction

    2 minutes after first infusion of remimazolam

  • dosage of sedative drugs

    First infusion until end of remimazolam administration

  • time records

    1 day

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    1 day

Study Arms (3)

Group R1

EXPERIMENTAL

The first induction dose of remimazolam is 0.1mg/kg.

Drug: Remimazolam

Group R2

EXPERIMENTAL

The first induction dose of remimazolam is 0.2mg/kg.

Drug: Remimazolam

Group R3

EXPERIMENTAL

The first induction dose of remimazolam is 0.3mg/kg.

Drug: Remimazolam

Interventions

RemimazolamDRUG

Observe the incidence of paradoxical reactions after the first induction.

Also known as: remimazolam besylate
Group R1Group R2Group R3

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-12 years old
  • ASA I-II level
  • Sign an informed consent form

You may not qualify if:

  • Developmental delay or neurological and psychiatric disorders
  • Severe malnutrition or severe obesity
  • High risk of stomach fullness and reflux aspiration
  • Allergic to benzodiazepines and opioids
  • Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
  • Severe sleep apnea
  • Abnormal liver and kidney function
  • Recently participated in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

remimazolam

Study Officials

  • aihua Du, Dr.

    Tongji Hospita

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

May 20, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)