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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: lidocaine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Hahnemann University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any person referred to the Hahnemann University Hospital Electrophysiology Laboratory for a clinically indicated ICD implant

Exclusion Criteria:

• Any person under the age of 18 years
• Inability to give an informed consent
• Allergy to lidocaine
• Receiving lidocaine treatment for pain or arrhythmia
• Contraindication for DFT testing
• Not consenting for DFT testing
• Receiving energy other than 10-12.5 joules as initial DFT test
• Implant of ICD on the right side
• DFT not planned to be performed during ICD implant
• Epicardial placement of ICD leads
• Use of single coil ICD lead
• Subpectoral ICD implantation
• Cephalic cutdown used for central venous access
• Require more than 3mg/kg of 1% SQ lidocaine for local anesthesia
• Pregnant women or prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; treatment arm	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
Placebo Comparator: Saline; placebo arm	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; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of successful defibrillation on first attempt with 10-12 joules.	These patients will 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. Outcome is to have a success defibrillation within the first attempt.	Through study completion but no longer than 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of failure to defibrillate at higher energy levels.	This outcome occurs when research team fails to defibrillate on any attempt.	Through study completion but no longer than 1 year
Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.	This outcome occurs when research team fails to defibrillate on first attempt.	Through study completion but no longer than 1 year

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Investigators: Principal Investigator: Bryan Chambers, Drexel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: lidocaine implantation ICD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 17283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes