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CompletedNCT06419543Updated Oct 30, 2024

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

An interventional study of Remimazolam in Endoscopy, Gastrointestinal, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2024-10-30.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
333
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study summary

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

Read the detailed description

Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.

02

Conditions studied

  • Endoscopy, Gastrointestinal
03

In context

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
333 participants (actual)

Study arms

  • Experimental
    Group R1

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

    Drug: Remimazolam

  • Experimental
    Group R2

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

    Drug: Remimazolam

  • Experimental
    Group R3

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

    Drug: Remimazolam

Interventions

  • DrugRemimazolam

    Observe the incidence of paradoxical reactions after the first induction.

    Also known as: remimazolam besylate

06

What researchers measure

Primary outcomes

  1. incidence of paradoxical reaction

    observe the incidence of paradoxical reaction within 2 minutes

    Time frame: 2 minutes after first infusion of remimazolam

Secondary outcomes

  1. performance and duration of paradoxical reaction

    observe the performance and duration of paradoxical reaction within 2 minutes

    Time frame: 2 minutes after first infusion of remimazolam

  2. dosage of sedative drugs

    Total dose of the first administered plus supplemental doses of sedative drugs.

    Time frame: First infusion until end of remimazolam administration

  3. time records

    anesthesia time, induction time, surgical time, awakening time, and recovery time

    Time frame: 1 day

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

    respiratory suppression incidence;intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.

    Time frame: 1 day

07

Study locations

1 site
  • Tongji hospital
    Wuhan, Hubei 430030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419543
Lead sponsor
Tongji Hospital
Responsible party
aijun xu (Clinical Professor, Tongji Hospital) — Principal investigator
First posted
May 17, 2024
Start date
May 20, 2024
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024
Last update
Oct 30, 2024

Study contacts

aihua Du, Dr.
study chair · Tongji Hospita

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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