Effectiveness of Nefopam for Thermoregulation During Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122665

Enrollment

Registered

2017-04-21

Start date

2004-08-31

Completion date

2006-01-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia

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.

Interventions

DRUGNefopam Low dose

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

DRUGNefopam High dose

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Blinded drug containers.

Intervention model description

Volunteers given two doses of nefopam in a crossover protocol.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Normal healthy volunteers ages 18-40

Exclusion criteria

* history of alcohol or drug abuse

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026