NCT03063866

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

Randomised Controlled Study Comparing Use of Popofol Plus Fentanyl Versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients With Advanced Liver Disease.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sherief Abd-Elsalam · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DRUG	Propofol	Propofol 1 mg/kg i.v
DRUG	Midazolam	Midazolam 3 mg i.v
DRUG	Fentanyl	fentanyl 0.5 ug/kg

Timeline

• Start date: 2017-02-21
• Primary completion: 2018-03-01
• Completion: 2018-04-01
• First posted: 2017-02-24
• Last updated: 2017-04-27

Locations

1 site across 1 country: Egypt