Effectiveness of Nefopam for Thermoregulation During Surgery

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Hypothermia

Clinical Trial Details

NCT number	NCT03122665
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	N/A
Start date	August 2004
Completion date	January 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Not yet recruiting	`NCT05306392` - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation	N/A
Completed	`NCT02685176` - Head and Torso Rewarming Using a Human Model for Severe Hypothermia	N/A
Completed	`NCT02586974` - Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response	N/A
Withdrawn	`NCT02812069` - WarmSmart Warming Protocol	N/A
Completed	`NCT02121574` - Accuracy of Zero-flux and Ingestible Thermometers	N/A
Not yet recruiting	`NCT02211703` - National Epidemiologic Survey on the Incidence of Perioperative Hypothermia	N/A
Completed	`NCT02742818` - Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models	N/A
Completed	`NCT02177903` - Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes	N/A
Recruiting	`NCT01866384` - Targeted Temperature Management After Intracerebral Hemorrhage	Phase 2
Active, not recruiting	`NCT01529658` - Renal Hypothermia During Partial Nephrectomy	N/A
Completed	`NCT01722955` - Pre-warmed Intravenous Fluids and Monitored Anesthesia Care	N/A
Completed	`NCT01793337` - Core Body Temperature Measurement During Hot and Cold Environmental Exposure	N/A
Completed	`NCT01559675` - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery	N/A
Terminated	`NCT01018576` - Delayed Cord Clamping in Premature Infants	N/A
Terminated	`NCT00822796` - Thermogard™ Efficacy Trial	N/A
Completed	`NCT00904228` - Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room	N/A
Completed	`NCT00334360` - Dexmed/Buspirone Synergism on Shivering	Phase 4
Not yet recruiting	`NCT06283771` - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering	N/A
Completed	`NCT04399902` - Study to Actively Warm Trauma Patients	N/A