Effectiveness of Nefopam for Thermoregulation During Surgery

NeuroTherapia, Inc.

Status: Completed

Conditions: Hypothermia

Treatments: Drug: Nefopam High dose; Drug: Nefopam Low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03122665

180/03

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal healthy volunteers ages 18-40

Exclusion criteria

• history of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Nefopam low dose

Active Comparator group

Description:

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

Treatment:

Drug: Nefopam Low dose

Nefopam high dose

Active Comparator group

Description:

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

Treatment:

Drug: Nefopam High dose