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Comparison the effectiveness and safety of the midazolam versus propofol for sedation of cirrhotic patients undergoing upper GI endoscopy

Comparison the effectiveness and safety of the midazolam versus propofol for sedation of cirrhotic patients undergoing upper GI endoscopy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201011048996N1
Enrollment
60
Registered
2020-11-03
Start date
2019-05-22
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Cirrhosis of liver. Unspecified cirrhosis of liver

Interventions

Intervention 1: Intervention group: At first, all patients are prescribed 2 micrograms per kilogram of fentanyl. Then patients in the first intervention group (M), Midazolam (Elixir Company) is prescr

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diagnosed liver patients (child Pugh class A or B and MELD = 24) that came for endoscopy and routine screening for varices.

Exclusion criteria

Exclusion criteria: Diagnosed allergies or reaction to sedative materials Suffering from significant respiratory diseases or respiratory tract abnormalities Active neurological disorders such as hepatic encephalopathy Advanced liver failure, decompensated (CP score > 10, MELD > 24, or child Pugh class C) Use of alcohol or unauthorized drugs Consumption of the sedative and narcotic drugs

Design outcomes

Primary

MeasureTime frame
Comparison of the effectiveness of the midazolam and propofol in sedation. Timepoint: Immediately after Infusion, 1s minute, 5th minute, at recovery. Method of measurement: Designed checklist based on similar studies.;Hemodynamic changes include blood pressure, heart rate, respiration rate, and blood oxygen levels. Timepoint: Immediately after Infusion, 1s minute, 5th minute, at recovery. Method of measurement: Using pulse oximetry and blood pressure monitor.;Sedation time and duration of sedation. Timepoint: At the duration of the study. Method of measurement: Ramsay standard criteria and checklist prepared.;Patient stays in recovery duration and discharge based on Aldrete Score. Timepoint: At the duration of the study. Method of measurement: Aldrete Score standard checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Besaratdar

Bandare-abbas University of Medical Sciences

Sepidehanzali@yahoo.com+98 76 3371 4731

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026