Back to resultsDexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea of Adult focused on measuring Dexmedetomidine, Sleep, Endoscopy, Propofol
Eligibility Criteria
Inclusion Criteria:
- age more than 18 years
- patients with obstructive sleep apnea
- ASA 1and2
Exclusion Criteria:
- patient refusal
- age less than 18 years
- morbid obesity
- known or suspected allergy to the studied drugs
Sites / Locations
- Zagazig university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
propofol
propofol-dex.
Arm Description
patients will receive only propofol intravenous infusion for sedation
patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation
Outcomes
Primary Outcome Measures
success of sedation
to complete the procedure with diagnosis of site and degree of obstruction
Secondary Outcome Measures
time until sufficient sedation
time till patient is ready to start endoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03091894
Brief Title
Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy
Official Title
Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2017 (Actual)
Primary Completion Date
April 8, 2018 (Actual)
Study Completion Date
April 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Essam Fathi
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
No
5. Study Description
Brief Summary
This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.
Detailed Description
Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
Keywords
Dexmedetomidine, Sleep, Endoscopy, Propofol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
patients will receive only propofol intravenous infusion for sedation
Arm Title
propofol-dex.
Arm Type
Active Comparator
Arm Description
patients will receive dexmedetomidine in addition to propofol intravenous infusion for sedation
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
diprivan
Intervention Description
propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
dexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group
Primary Outcome Measure Information:
Title
success of sedation
Description
to complete the procedure with diagnosis of site and degree of obstruction
Time Frame
the duration of the procedure under sedation is usually about 20 minutes
Secondary Outcome Measure Information:
Title
time until sufficient sedation
Description
time till patient is ready to start endoscopy
Time Frame
about 5-10 minutes from start of sedation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18 years
patients with obstructive sleep apnea
ASA 1and2
Exclusion Criteria:
patient refusal
age less than 18 years
morbid obesity
known or suspected allergy to the studied drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
essam f abdelgalel, A.professor
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig university
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
002055
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy
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