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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03117166
• Other study ID #: 17283
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 24, 2011
• Last updated: May 8, 2017
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: May 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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
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

Locations

Country	Name	City	State
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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