NCT03122665

Effectiveness of Nefopam for Thermoregulation During Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypothermia

Interventions

Type	Name	Description
DRUG	Nefopam Low dose	Continuous intravenous infusion at 0.5 mg/ml for three hours.
DRUG	Nefopam High dose	Continuous intravenous infusion at 1.0 mg/ml for three hours.

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2017-04-21
• Last updated: 2020-06-18

Locations

1 site across 1 country: Switzerland