Effectiveness of Nefopam for Thermoregulation During Surgery | NCT03122665

Studies
Effectiveness of Nefopam for Thermoregulation During Surgery

NCT03122665

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Jun 18, 2020Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Hypothermia

Interventions

Nefopam Low dose
Nefopam High dose

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Oct 26, 2016

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 18, 2020Actual

Name	Class
Laboratoires Biocodex (Montrouge, France)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nefopam low dose	Active Comparator	Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours.	Drug: Nefopam Low dose
Nefopam high dose	Active Comparator	Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours.	Drug: Nefopam High dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nefopam Low dose	Drug	Continuous intravenous infusion at 0.5 mg/ml for three hours.	Nefopam low dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal healthy volunteers ages 18-40

Exclusion Criteria:

history of alcohol or drug abuse

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, University of Bern		Bern	Freiburgstrasses	3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007035	Hypothermia

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009340	Nefopam

Ancestor Terms

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided