Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation
NCT ID: NCT01749579
Last Updated: 2012-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2012-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Propofol
The patients will receive propofol for sedation in addition to fentanyl
Propofol
Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
Fentanyl
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
Midazolam
The patients will receive midazolam for sedation in addition to fentanyl
Midazolam
Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
Fentanyl
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
Interventions
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Propofol
Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
Midazolam
Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
Fentanyl
Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
Eligibility Criteria
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Inclusion Criteria
* candidate for a painful procedure
* negative past history of a serious medical condition
* ASA score 0 and 1
Exclusion Criteria
* pregnancy
* allergy to drugs
* hemodynamic instability
* failure to consent
18 Years
90 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Mohammad Jalili, MD
Role: STUDY_CHAIR
Tehran University of Medical Sciences
Locations
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Imam Khomeini Hospital
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Other Identifiers
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130-2640
Identifier Type: -
Identifier Source: org_study_id