CompletedPhase 3

Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

China378 participantsStarted 2017-09-01

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.

Who can participate

Age range

18 Years – 60 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: * subjects aged 18-60 years； * intending to undergo diagnostic upper GI endoscopy; * ASA( American Society of Anesthesiologists) I or II； * 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²; * the operation time of gastroscopy is not more than 30 min； * Signed informed consent. Exclusion Criteria: * Patients need to be Complicated gastroscopy; * Patients need to be Tracheal intubation; * Patients with respiratory management difficulties (Modified Mallampati grade IV）; * one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); * A history of drug abuse and / or alcohol abuse 2 years prior to the screening period； * allergic to drugs used in the study; * pregnant women or those in lactation period * The subject has participated in other clinical trial within the 3 months prior to randomization.

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

rate of successful sedation

Timeframe: approximately 3 hours

Trial details

NCT IDNCT03425474

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-10

View on ClinicalTrials.gov More Sedation trials

Who can participate

Age range

18 Years – 60 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.