Effectiveness of Nefopam for Thermoregulation During Surgery

June 16, 2020 updated by: The Cleveland Clinic
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Freiburgstrasses
      • Bern, Freiburgstrasses, Switzerland, 3010
        • Department of Anesthesiology, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal healthy volunteers ages 18-40

Exclusion Criteria:

  • history of alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
V1
Time Frame: three hours of infusion
Volume of distribution 1
three hours of infusion
V2
Time Frame: three hours of infusion
Volume of distribution2
three hours of infusion
CLel
Time Frame: three hours of infusion
Clearance
three hours of infusion
CLdist
Time Frame: three hours of infusion
Clearance distribution
three hours of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Laboratoires Biocodex (Montrouge, France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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