CompletedNot Applicable

Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

China106 participantsStarted 2023-01-18

Plain-language summary

To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Who can participate

Age range

1 Month – 17 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 0-17; * ASA Class I-II; * Sign the informed consent form. Exclusion Criteria: * Patients with high risk of stomach satiety and reflux aspiration; * Patients allergic to the study drug; * Obesity or severe malnutrition; * Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; * Hypertension without treatment; * Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range); * Other congenital diseases or acute and chronic diseases that affect the observation of curative effect; * Participate in other clinical studies within 4 weeks.

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

Sedation success rate

Timeframe: Procedure (From the beginning of anesthesia to the end of examination)

Trial details

NCT IDNCT05686863

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-07

View on ClinicalTrials.gov More Drug Effect trials

Who can participate

Age range

1 Month – 17 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.