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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06419543

Enrollment

333

Registered

2024-05-17

Start date

2024-05-20

Completion date

2024-10-01

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Gastrointestinal

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.

Interventions

DRUGRemimazolam

Observe the incidence of paradoxical reactions after the first induction.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
time records	1 day	anesthesia time, induction time, surgical time, awakening time, and recovery time
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026