CompletedNot Applicable

Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Israel60 participantsStarted 2008-07

Plain-language summary

Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.

Who can participate

Age range

18 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: * Known chronic liver disease (Child-Pugh class A or B) who presented for upper GI endoscopy for routine variceal screening. * The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available. * Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites. Exclusion Criteria: * Exclusion criteria will include the following: * known allergy or adverse reaction to sedative or component thereof * patients with known significant respiratory disease or airway abnormality) * active neurological impairment including clinically detectable hepatic encephalopathy * advanced or decompensated liver disease ( CP score \>10, MELD \>24) (Child-Pugh class C) * active alcohol consumption or illicit drug abuse * active prescription for sedation or narcotics

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

Exacerbation of hepatic encephalopathy

Trial details

NCT IDNCT01141036

SponsorZiv Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Cirrhosis trials

Who can participate

Age range

18 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.