Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.

Phase 4

• Conditions: Liver Diseases
• Interventions: Drug: Midazolam; Drug: Propofol; Drug: Fentanyl

• Registration Number: NCT03063866
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

Gastrointestinal endoscopy is a frequent procedure in the patients with advanced liver disease. It requires variable degree of sedation ranging from minimal sedation to general anesthesia aiming for relieving pain, anxiety, and bad memories of the procedure.

In conscious sedation, patients are able to make purposeful responses to auditory and tactile clues, with maintenance of ventilatory and circulatory stability. while, in deep sedation, patients respond only to painful stimuli, and airway support is frequently required. At the level of general anesthesia, patients are unresponsive, and airway support is mandatory.

Detailed Description

The aim of this study is to compare use of propofol or midazolam as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Primary Completion: 2018-03
• Study Completion: 2018-04

Recruitment & Eligibility

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

Inclusion Criteria

• Patients aged between 40 and 60 years old.
• With Child score B or C
• Presented for elective gastrointestinal endoscopy

Exclusion Criteria

• Emergent condition like hematemesis.
• Patients with moderate to severe hepatic encephalopathy.
• Patients with hepatopulmonary syndrome.
• Patients with known or suspected hypersensitivity to the used medication were also excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P Group	Fentanyl	Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v
M group	Midazolam	Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
M group	Fentanyl	Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
P Group	Propofol	Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v

Primary Outcome Measures

Name	Time	Method
Level of sedation	6 months	Level of sedation using Ramsay sedation agitation score at before induction of sedation

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Cairo, Egypt