Back to resultsPropofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Primary Purpose
Colonic Diseases
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Diseases
Eligibility Criteria
Inclusion Criteria:
- aged 25-45 years,
- ASA class I or II,
- who are scheduled for elective outpatient colonoscopy
Exclusion Criteria:
- refused to give informed consent
- if they had known hypersensitivity to the used drugs
- patients with morbidly obese patients
- patients with increased risk for airway obstruction as obstructive sleep apnea,
- Liver diseases
Sites / Locations
- Sameh Abdelkhalek AhmedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
• Propofol Group
• Dexmedetomidine Group
Arm Description
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
Outcomes
Primary Outcome Measures
Number of patients with adequate sedation
the number of patients adequately sedated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03466632
Brief Title
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Official Title
Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
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
Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Detailed Description
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
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
• Propofol Group
Arm Type
Active Comparator
Arm Description
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..
Arm Title
• Dexmedetomidine Group
Arm Type
Active Comparator
Arm Description
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
Primary Outcome Measure Information:
Title
Number of patients with adequate sedation
Description
the number of patients adequately sedated
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 25-45 years,
ASA class I or II,
who are scheduled for elective outpatient colonoscopy
Exclusion Criteria:
refused to give informed consent
if they had known hypersensitivity to the used drugs
patients with morbidly obese patients
patients with increased risk for airway obstruction as obstructive sleep apnea,
Liver diseases
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
Tanta University
Official's Role
Study Director
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
Sameh Abdelkhalek Ahmed
City
Zagazig
ZIP/Postal Code
35455
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalek Ahmed, MD
Phone
00201095159522
Email
sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
We'll reach out to this number within 24 hrs