Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia
Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Continuous intravenous infusion at 0.5 mg/ml for three hours.
Continuous intravenous infusion at 1.0 mg/ml for three hours.
Department of Anesthesiology, University of Bern
Bern, Freiburgstrasses, Switzerland
V1
Volume of distribution 1
Time frame: three hours of infusion
V2
Volume of distribution2
Time frame: three hours of infusion
CLel
Clearance
Time frame: three hours of infusion
CLdist
Clearance distribution
Time frame: three hours of infusion
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