Effectiveness of Nefopam for Thermoregulation During Surgery
- Conditions
- Hypothermia
- Interventions
- Registration Number
- NCT03122665
- Lead Sponsor
- The Cleveland Clinic
- Brief Summary
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Normal healthy volunteers ages 18-40
- history of alcohol or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nefopam low dose Nefopam Low dose Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours. Nefopam high dose Nefopam High dose Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.
- Primary Outcome Measures
Name Time Method V1 three hours of infusion Volume of distribution 1
V2 three hours of infusion Volume of distribution2
CLel three hours of infusion Clearance
CLdist three hours of infusion Clearance distribution
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Anesthesiology, University of Bern
🇨🇭Bern, Freiburgstrasses, Switzerland