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

Primary Purpose

Liver Diseases

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Propofol
Midazolam
Fentanyl
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

M group

P Group

Arm Description

Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg

Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v

Outcomes

Primary Outcome Measures

Level of sedation
Level of sedation using Ramsay sedation agitation score at before induction of sedation

Secondary Outcome Measures

Full Information

First Posted
February 21, 2017
Last Updated
April 25, 2017
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03063866
Brief Title
Randomised Controlled Study of Popofol Versus Midazolam as Sedation in Endoscopy With Advanced Liver Disease.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M group
Arm Type
Active Comparator
Arm Description
Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg
Arm Title
P Group
Arm Type
Active Comparator
Arm Description
Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
propoven
Intervention Description
Propofol 1 mg/kg i.v
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum
Intervention Description
Midazolam 3 mg i.v
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fantanyl
Intervention Description
fentanyl 0.5 ug/kg
Primary Outcome Measure Information:
Title
Level of sedation
Description
Level of sedation using Ramsay sedation agitation score at before induction of sedation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Sameh Abdelkhalek Ahmed, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Tanta university Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Phone
00201095159522
Email
sherif_tropical@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29312786
Citation
Ahmed SA, Selim A, Hawash N, Tawfik AK, Yousef M, Kobtan A, Badawi R, Elnawasany S, Elkhouly RA, Hanafy AS, Rizk FH, Mansour L, Abd-Elsalam S. Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease. Int J Hepatol. 2017;2017:8462756. doi: 10.1155/2017/8462756. Epub 2017 Sep 26.
Results Reference
derived

Learn more about this trial

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

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