Back to resultsComparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
Primary Purpose
Emergencies
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Propofol
Midazolam
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Emergencies focused on measuring propofol, midazolam, duration of recovery, emergency procedure
Eligibility Criteria
Inclusion Criteria:
- age more than 18
- candidate for a painful procedure
- negative past history of a serious medical condition
- ASA score 0 and 1
Exclusion Criteria:
- deep sedation making the patient unable to answer the questions
- pregnancy
- allergy to drugs
- hemodynamic instability
- failure to consent
Sites / Locations
- Imam Khomeini HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propofol
Midazolam
Arm Description
The patients will receive propofol for sedation in addition to fentanyl
The patients will receive midazolam for sedation in addition to fentanyl
Outcomes
Primary Outcome Measures
Recovery time
Length of time before complete recovery from sedation is achieved
Secondary Outcome Measures
Patients' Pain perception
Pain perception as measured by verbal numeric rating scale
Full Information
NCT ID
NCT01749579
First Posted
December 6, 2012
Last Updated
December 11, 2012
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01749579
Brief Title
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
Official Title
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
propofol, midazolam, duration of recovery, emergency procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Experimental
Arm Description
The patients will receive propofol for sedation in addition to fentanyl
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
The patients will receive midazolam for sedation in addition to fentanyl
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
Primary Outcome Measure Information:
Title
Recovery time
Description
Length of time before complete recovery from sedation is achieved
Time Frame
Within one hour after sedation
Secondary Outcome Measure Information:
Title
Patients' Pain perception
Description
Pain perception as measured by verbal numeric rating scale
Time Frame
Within one hour after sedation
Other Pre-specified Outcome Measures:
Title
Blood pressure
Time Frame
Within one hour after sedation
Title
Oxygen saturation
Time Frame
Within one hour after sedation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18
candidate for a painful procedure
negative past history of a serious medical condition
ASA score 0 and 1
Exclusion Criteria:
deep sedation making the patient unable to answer the questions
pregnancy
allergy to drugs
hemodynamic instability
failure to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Jalili, MD
Phone
+98(912)5483998
Email
mjalili@tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Imam Khomeini Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
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