Back to resultsPropofol Versus Midazolam for Lower Gastrointestinal Endoscopy
Primary Purpose
Cirrhosis, Liver
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Midazolam
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver
Eligibility Criteria
Inclusion Criteria:
- Liver cirrhosis
- presented to colonoscopy
Exclusion Criteria:
- Encephalopathy
- Hypersensitivity
- Coagulopathy
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Midazolam
Propofol
Arm Description
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
Outcomes
Primary Outcome Measures
Number of patients adequately sedated
The number of patients adequately sedated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03388151
Brief Title
Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
November 11, 2022 (Anticipated)
Study Completion Date
December 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
Primary Outcome Measure Information:
Title
Number of patients adequately sedated
Description
The number of patients adequately sedated
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver cirrhosis
presented to colonoscopy
Exclusion Criteria:
Encephalopathy
Hypersensitivity
Coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalek Ahmed, MD
Organizational Affiliation
Tanta University Anasthesia Department
Official's Role
Study Director
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Propofol Versus Midazolam for Lower Gastrointestinal Endoscopy
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