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Effectiveness of Nefopam for Thermoregulation During Surgery

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nefopam Low dose
Nefopam High dose
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal healthy volunteers ages 18-40

Exclusion Criteria:

  • history of alcohol or drug abuse

Sites / Locations

  • Department of Anesthesiology, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nefopam low dose

Nefopam high dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

V1
Volume of distribution 1
V2
Volume of distribution2
CLel
Clearance
CLdist
Clearance distribution

Secondary Outcome Measures

Full Information

First Posted
October 26, 2016
Last Updated
June 16, 2020
Sponsor
The Cleveland Clinic
Collaborators
Laboratoires Biocodex (Montrouge, France)
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1. Study Identification

Unique Protocol Identification Number
NCT03122665
Brief Title
Effectiveness of Nefopam for Thermoregulation During Surgery
Official Title
Effectiveness of Nefopam for Thermoregulation During Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Laboratoires Biocodex (Montrouge, France)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Volunteers given two doses of nefopam in a crossover protocol.
Masking
ParticipantInvestigator
Masking Description
Blinded drug containers.
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nefopam low dose
Arm Type
Active Comparator
Arm Description
Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.
Arm Title
Nefopam high dose
Arm Type
Active Comparator
Arm Description
Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.
Intervention Type
Drug
Intervention Name(s)
Nefopam Low dose
Other Intervention Name(s)
Low
Intervention Description
Continuous intravenous infusion at 0.5 mg/ml for three hours.
Intervention Type
Drug
Intervention Name(s)
Nefopam High dose
Other Intervention Name(s)
High
Intervention Description
Continuous intravenous infusion at 1.0 mg/ml for three hours.
Primary Outcome Measure Information:
Title
V1
Description
Volume of distribution 1
Time Frame
three hours of infusion
Title
V2
Description
Volume of distribution2
Time Frame
three hours of infusion
Title
CLel
Description
Clearance
Time Frame
three hours of infusion
Title
CLdist
Description
Clearance distribution
Time Frame
three hours of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal healthy volunteers ages 18-40 Exclusion Criteria: history of alcohol or drug abuse
Facility Information:
Facility Name
Department of Anesthesiology, University of Bern
City
Bern
State/Province
Freiburgstrasses
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Nefopam for Thermoregulation During Surgery

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