Effectiveness of Nefopam for Thermoregulation During Surgery

Status Completed

Clinical Trial Summary

Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hypothermia

Clinical Trial Details

NCT number	NCT03122665
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	August 2004
Completion date	January 2006

View Details

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