Clinical trial

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: a Prospective Observation Study

NCT06419543

Name

PRPG

Description

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

Trial arms

Trial start

2024-05-20

Estimated PCD

2024-10-01

Trial end

2024-10-31

Status

Not yet recruiting

Treatment

Remimazolam

Observe the incidence of paradoxical reactions after the first induction.

Arms:

0.1mg/kg of remimazolam, 0.2mg/kg of remimazolam, 0.3mg/kg of remimazolam

Other names:

remimazolam besylate

Size

120

Primary endpoint

incidence of paradoxical reaction

2 minutes after first infusion of remimazolam

Eligibility criteria

Inclusion Criteria: * Age 1-18 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 24 hours; Severe sleep apnea; Abnormal liver and kidney function; Recently participated in other clinical studies.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

1 product

2 indications

Organization

Product

Indication

Indication