Effectiveness of Nefopam for Thermoregulation During Surgery

Hypothermia Clinical Trial

Official title:

Effectiveness of Nefopam for Thermoregulation During Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122665
• Other study ID #: 180/03
• Status: Completed
• Phase: N/A
• Start date: August 2004
• Est. completion date: January 2006

Study information

• Verified date: June 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normal healthy volunteers ages 18-40

Exclusion Criteria:

• history of alcohol or drug abuse

Related Conditions & MeSH terms

• Hypothermia

Intervention

Drug:
• Nefopam Low dose
Continuous intravenous infusion at 0.5 mg/ml for three hours.
• Nefopam High dose
Continuous intravenous infusion at 1.0 mg/ml for three hours.

Locations

Country	Name	City	State
Switzerland	Department of Anesthesiology, University of Bern	Bern	Freiburgstrasses

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Laboratoires Biocodex (Montrouge, France)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	V1	Volume of distribution 1	three hours of infusion
Primary	V2	Volume of distribution2	three hours of infusion
Primary	CLel	Clearance	three hours of infusion
Primary	CLdist	Clearance distribution	three hours of infusion