Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Endoscopy, Gastrointestinal
• Intervention / Treatment: Drug: Remimazolam

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 Type: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Study Population

We select children who choose to have a painless gastrointestinal endoscopy at Tongji Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group R1; The first induction dose of remimazolam is 0.1mg/kg.	Drug: Remimazolam; Observe the incidence of paradoxical reactions after the first induction.; Other Names: remimazolam besylate
Experimental: Group R2; The first induction dose of remimazolam is 0.2mg/kg.	Drug: Remimazolam; Observe the incidence of paradoxical reactions after the first induction.; Other Names: remimazolam besylate
Experimental: Group R3; The first induction dose of remimazolam is 0.3mg/kg.	Drug: Remimazolam; Observe the incidence of paradoxical reactions after the first induction.; Other Names: remimazolam besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of paradoxical reaction	observe the incidence of paradoxical reaction within 2 minutes	2 minutes after first infusion of remimazolam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
performance and duration of paradoxical reaction	observe the performance and duration of paradoxical reaction within 2 minutes	2 minutes after first infusion of remimazolam
dosage of sedative drugs	Total dose of the first administered plus supplemental doses of sedative drugs.	First infusion until end of remimazolam administration
time records	anesthesia time, induction time, surgical time, awakening time, and recovery time	1 day
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.	1 day

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: aihua Du, Dr., Tongji Hospita

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PRPG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No