Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Endoscopy, Gastrointestinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419543
• Other study ID #: PRPG
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Endoscopy, Gastrointestinal

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