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

Phase 2

• Conditions: Cirrhosis of liver.; Unspecified cirrhosis of liver; K74.60

• Registration Number: IRCT20201011048996N1
• Lead Sponsor: Bandare-abbas University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.