CompletedNot Applicable

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

China333 participantsStarted 2024-05-20

Plain-language summary

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

Who can participate

Age range

1 Year – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

incidence of paradoxical reaction

Timeframe: 2 minutes after first infusion of remimazolam

Trial details

NCT IDNCT06419543

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Endoscopy, Gastrointestinal trials

Who can participate

Age range

1 Year – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.