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Effectiveness of Nefopam for Thermoregulation During Surgery

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03122665
Collaborator
Laboratoires Biocodex (Montrouge, France) (Other)
8
Enrollment
1
Location
2
Arms
17
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Nefopam Low dose
  • Drug: Nefopam High dose
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Volunteers given two doses of nefopam in a crossover protocol.Volunteers given two doses of nefopam in a crossover protocol.
Masking:
Double (Participant, Investigator)
Masking Description:
Blinded drug containers.
Primary Purpose:
Treatment
Official Title:
Effectiveness of Nefopam for Thermoregulation During Surgery
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nefopam low dose

Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.

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

    		•
    Active Comparator: Nefopam high dose

    Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. V1 [three hours of infusion]

      Volume of distribution 1

    2. V2 [three hours of infusion]

      Volume of distribution2

    3. CLel [three hours of infusion]

      Clearance

    4. CLdist [three hours of infusion]

      Clearance distribution

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal healthy volunteers ages 18-40
    Exclusion Criteria:
    • history of alcohol or drug abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, University of Bern Bern Freiburgstrasses Switzerland 3010

    Sponsors and Collaborators

    • The Cleveland Clinic
    • Laboratoires Biocodex (Montrouge, France)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT03122665
    Other Study ID Numbers:
    • 180/03
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Jun 18, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The Cleveland Clinic
    Nefopam
    Pharmacokinetics
    Shivering,
    Thermoregulation
    Anesthesia
    Additional relevant MeSH terms:
    Hypothermia
    Nefopam

    Study Results

    No Results Posted as of Jun 18, 2020