Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Randomised Study Comparing the Use of Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
1 other identifier
interventional
100
1 country
1
Brief Summary
Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMarch 15, 2018
March 1, 2018
4 years
March 9, 2018
March 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with adequate sedation
the number of patients adequately sedated
6 months
Study Arms (2)
• Propofol Group
ACTIVE COMPARATORpropofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..
• Dexmedetomidine Group
ACTIVE COMPARATORdexmedetomidine 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
Interventions
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
Eligibility Criteria
You may qualify if:
- aged 25-45 years,
- ASA class I or II,
- who are scheduled for elective outpatient colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Sameh Abdelkhalek Ahmed
Zagazig, 35455, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sherief Abd-Elsalam, MD
Tanta University
- STUDY DIRECTOR
Sameh Abdelkhalek Ahmed, MD
Tanta University Anasthesia Department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
March 9, 2018
First Posted
March 15, 2018
Study Start
April 1, 2016
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
March 15, 2018
Record last verified: 2018-03