NCT03117166

Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Drexel University College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement.

Detailed description

Summary: The purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (ICD) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose. During implantation of an ICD, defibrillation threshold (DFT) testing is performed. DFT is calibrated as the lowest energy delivered by the ICD that will successfully terminate malignant arrhythmia. Lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. Experimentally, lidocaine has been shown to increase thresholds during DFT' testing due to the drugs dual effect. The rationale behind this project is that the lidocaine may yield falsely elevated DFT, resulting in higher calibration of the ICD device. This alteration can affect ICD battery and overall ICD life. Comparisons between study groups may elucidate effects of IV lidocaine on DFT.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	lidocaine	A one time bolus of lidocaine 0.5 mg/kg iv will be administered just prior to IV propofol injection,then successful defibrillation will be ascertained
DRUG	Placebo	A control group will get an IV bolus of 0.9% NS just prior to IV bolus of propofol, then successful defibrillation will be ascertained

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2017-04-17
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study