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Evaluation of sedation with propofol versus midazolam for endoscopic injection sclerotherapy in patients with liver cirrhosis: Randomized controlled trial.

Evaluation of sedation with propofol versus midazolam for endoscopic injection sclerotherapy in patients with liver cirrhosis: Randomized controlled trial. - RCT of EIS with propofol versus midazolam.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017173
Enrollment
20
Registered
2015-04-19
Start date
2014-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal varix

Interventions

Using propofol for sedation during endoscopic injection sclerotherapy Using midazolam for sedation during endoscopic injection sclerotherapy

Sponsors

Department of Endoscopy, Fukushima Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Patient with liver cirrhosis who will be prophylactically performed endoscopic injection sclerotherapy for esophageal varix. 2.ECOG-Performance Status is 0 or1. 3. Patient without overtminimal hepatic encephalopathy. 4. Patient must provide written consent to participate in the study. 5. Patient without allergy to propofol and midazolam.

Exclusion criteria

Exclusion criteria: 1. Patients with an American Society of Anesthesiologists (ASA) physical status of class 3, 4, 5. 2. Patients with active variceal bleeding. or past variceal bleeding. 3. Recurrent case after the treatment for esopageal varices. 4. Patients with severe liver failure(T.bil 4mg/gl, Child-Pugh score C). 5. Patients with severe renal failure. 6. Patients with overtminimal hepatic encephalopathy. 7. Patients with dementia, psychiatric illness. 8. Patient with comsumption of neuroactive medication. 9. Patient with drug abuse. 10. Patient with ongoing alcohol comsumption 2 weeks before the tratment. 11. Patient with allergy to propofol and midazolam. 12. Patient who have been judged as psychotic manifestation.

Design outcomes

Primary

MeasureTime frame
minimal hepatic encephalopathy after endoscopic injection sclerotherapy

Countries

Japan

Contacts

Public ContactKo Watanabe

Fukushima Medical University Hospital Department of Endoscopy

ko-wtn@ya2.so-net.ne.jp024-547-1583

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026