Controlled Hypotension During Functional Endoscopic Sinus Surgery
NCT ID: NCT01956981
Last Updated: 2013-10-08
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
PHASE4
60 participants
INTERVENTIONAL
2012-01-31
2013-07-31
Brief Summary
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Detailed Description
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Methods: Sixty patients aged between 18-65 years were enrolled. Patients were divided into two groups. In the magnesium sulfate group (Group M) patients were administered 40 kg-1 magnesium sulfate in 100 ml saline solution in 10 minutes as IV loading dose 10 minutes before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. In the dexmedetomidine group (Group D) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1 dexmedetomidine during the surgery. Deliberate hypotension was defined as a mean arterial pressure (MAP) being 60-70 mmHg.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Magnesium
40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.
Magnesium Sulfate
40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.
Dexmedetomidine
1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.
Dexmedetomidine
1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.
Interventions
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Magnesium Sulfate
40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.
Dexmedetomidine
1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* weight exceeding the ideal body weight more than 30%,
* Being treated with calcium channel blockers, non-steroidal anti-inflammatory drugs, agents affecting neuromuscular blockage,and agents contraindicated for controlled hypotension
18 Years
65 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Adnan Bayram
Assisstant Professor
Principal Investigators
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Adnan Bayram, Asst. Prof.
Role: STUDY_CHAIR
TC Erciyes University
Other Identifiers
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2011-221
Identifier Type: -
Identifier Source: org_study_id