Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

NCT ID: NCT06419543

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2024-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Endoscopy, Gastrointestinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group R1

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Observe the incidence of paradoxical reactions after the first induction.

Group R2

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Observe the incidence of paradoxical reactions after the first induction.

Group R3

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Observe the incidence of paradoxical reactions after the first induction.

Interventions

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Remimazolam

Observe the incidence of paradoxical reactions after the first induction.

Intervention Type DRUG

Other Intervention Names

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remimazolam besylate

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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aihua Du, Dr.

Role: STUDY_CHAIR

Tongji Hospita

Locations

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Tongji hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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PRPG

Identifier Type: -

Identifier Source: org_study_id

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