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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06419543
Other study ID # PRPG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 20, 2024
Est. completion date October 31, 2024

Study information

Verified date May 2024
Source Tongji Hospital
Contact mujun Chang, doctor
Phone +862783663625
Email changmujun@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 31, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam
Observe the incidence of paradoxical reactions after the first induction.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Outcome

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