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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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2013-12-31
2014-12-31
Brief Summary
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Detailed Description
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Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pethidine 0.4mg/kg iv
interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
Pethidine 0.4mg/kg
2ml intravenous bolus slowly injected in 2minutes.
DEX. I
Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.
Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
DEX. II
Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
DEX III
Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.
Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Interventions
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Pethidine 0.4mg/kg
2ml intravenous bolus slowly injected in 2minutes.
Dexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Initial body temperature \>38 C or \<36 C and those with a history of convulsions
* Multiple allergies
* Thyroid disease
* Parkinson's disease
* Dysautonomia
* Raynaud's syndrome
* Hypertension
* Coronary artery disease or other cardio-respiratory or neuromuscular pathology
* Middle ear pathology
* A known history of alcohol use
* Treatment with sedative hypnotic agents or vasodilators
* Having contraindications to spinal anesthesia
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hala Saad Abdel-Ghaffar
Assistant professor in anesthesia department, faculty of medicine, Assiut university
Principal Investigators
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Hala S Abdel-Ghaffar, MD
Role: PRINCIPAL_INVESTIGATOR
assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt
Locations
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Assiut university hospital, Assiut, Egypt
Asyut, Assiut Governorate, Egypt
Countries
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References
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Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
Other Identifiers
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IRB00008718
Identifier Type: -
Identifier Source: org_study_id
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