Clinical trial NCT03117166: Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing
Official title: Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pain
Keywords: lidocaine implantation ICD
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of successful defibrillation on first attempt with 10-12 joules.
timeFrame: Through study completion but no longer than 1 year
Secondary outcomes:
measure: Incidence of failure to defibrillate at higher energy levels.
timeFrame: Through study completion but no longer than 1 year
measure: Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.
timeFrame: Through study completion but no longer than 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel
name: Bryan Chambers
role: PRINCIPAL_INVESTIGATOR
References: