Clinical Trial: Effectiveness of Nefopam for Thermoregulation During Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Nefopam for Thermoregulation During Surgery

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

Detailed Summary:

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.

Sponsor: The Cleveland Clinic

Current Primary Outcome:

• V1 [ Time Frame: three hours of infusion ]
  Volume of distribution 1
• V2 [ Time Frame: three hours of infusion ]
  Volume of distribution2
• CLel [ Time Frame: three hours of infusion ]
  Clearance
• CLdist [ Time Frame: three hours of infusion ]
  Clearance distribution

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Cleveland Clinic

Dates:
Date Received: October 26, 2016
Date Started: August 2004
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017