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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063866
• Other study ID #: Sameh 1
• Status: Recruiting
• Phase: Phase 4
• First received: February 21, 2017
• Last updated: April 25, 2017
• Start date: February 21, 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, MD
• Phone: 00201095159522
• Email: Sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Drug:
• Propofol
Propofol 1 mg/kg i.v
• Midazolam
Midazolam 3 mg i.v
• Fentanyl
fentanyl 0.5 ug/kg

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of sedation	Level of sedation using Ramsay sedation agitation score at before induction of sedation	6 months