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OpenTrials
Completed

NCT Number: NCT03122665

Effectiveness of Nefopam for Thermoregulation During Surgery

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

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, University of Bern

Bern, Freiburgstrasses, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal healthy volunteers ages 18-40

Exclusion criteria

  • history of alcohol or drug abuse

Treatment and study plan

Nefopam Low dose

Drug

Continuous intravenous infusion at 0.5 mg/ml for three hours.

Other names: Low

Nefopam High dose

Drug

Continuous intravenous infusion at 1.0 mg/ml for three hours.

Other names: High

Primary outcomes

  1. V1

    Time frame: three hours of infusion

    Volume of distribution 1

  2. V2

    Time frame: three hours of infusion

    Volume of distribution2

  3. CLel

    Time frame: three hours of infusion

    Clearance

  4. CLdist

    Time frame: three hours of infusion

    Clearance distribution

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Laboratoires Biocodex (Montrouge, France)

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Apr 21, 2017
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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