Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy

Phase 3

• Conditions: Cirrhosis, Liver
• Interventions: Drug: Propofol; Drug: Midazolam

• Registration Number: NCT03388151
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy

Detailed Description

Effect of use of propofol versus use of midazolam as sedative agent in patients with liver cirrhosis presented for lower gastrointestinal endoscopy, Randomised controlled trial.

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-12-23
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27
• Primary Completion: 2022-11-11
• Study Completion: 2022-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Liver cirrhosis
• presented to colonoscopy

Exclusion Criteria

• Encephalopathy
• Hypersensitivity
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
Midazolam	Midazolam	Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation

Primary Outcome Measures

Name	Time	Method
Number of patients adequately sedated	6 months	The number of patients adequately sedated

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt