Effectiveness of Nefopam for Thermoregulation During Surgery
NCT ID: NCT03122665
Last Updated: 2020-06-18
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
NA
8 participants
INTERVENTIONAL
2004-08-31
2006-01-31
Brief Summary
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Detailed Description
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Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Nefopam low dose
Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.
Nefopam Low dose
Continuous intravenous infusion at 0.5 mg/ml for three hours.
Nefopam high dose
Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.
Nefopam High dose
Continuous intravenous infusion at 1.0 mg/ml for three hours.
Interventions
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Nefopam Low dose
Continuous intravenous infusion at 0.5 mg/ml for three hours.
Nefopam High dose
Continuous intravenous infusion at 1.0 mg/ml for three hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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Laboratoires Biocodex (Montrouge, France)
UNKNOWN
The Cleveland Clinic
OTHER
Responsible Party
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Locations
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Department of Anesthesiology, University of Bern
Bern, Freiburgstrasses, Switzerland
Countries
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Other Identifiers
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180/03
Identifier Type: -
Identifier Source: org_study_id
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