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

NCT ID: NCT03117166

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

treatment arm

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

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

Saline

placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryan Chambers

Role: PRINCIPAL_INVESTIGATOR

Drexel

Locations

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

17283

Identifier Type: -

Identifier Source: org_study_id