Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Not Applicable

Completed

• Conditions: Endoscopy, Gastrointestinal
• Interventions: Drug: Remimazolam

• Registration Number: NCT06419543
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-17
• Study Start: 2024-05-20
• Status Verified: 2024-10
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R1	Remimazolam	The first induction dose of remimazolam is 0.1mg/kg.
Group R2	Remimazolam	The first induction dose of remimazolam is 0.2mg/kg.
Group R3	Remimazolam	The first induction dose of remimazolam is 0.3mg/kg.

Primary Outcome Measures

Name	Time	Method
incidence of paradoxical reaction	2 minutes after first infusion of remimazolam	observe the incidence of paradoxical reaction within 2 minutes

Secondary Outcome Measures

Name	Time	Method
time records	1 day	anesthesia time, induction time, surgical time, awakening time, and recovery time
performance and duration of paradoxical reaction	2 minutes after first infusion of remimazolam	observe the performance and duration of paradoxical reaction within 2 minutes
dosage of sedative drugs	First infusion until end of remimazolam administration	Total dose of the first administered plus supplemental doses of sedative drugs.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 day	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.

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China