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

NCT03117166 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 17283
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

lidocaine implantation ICD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of failure to defibrillate at higher energy levels.

  Through study completion but no longer than 1 year

• Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.

  Through study completion but no longer than 1 year

Study Arms (2)

Lidocaine

EXPERIMENTAL

treatment arm

Drug: lidocaine

Saline

PLACEBO COMPARATOR

placebo arm

Drug: Placebo

Interventions

lidocaine 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

Lidocaine

Placebo 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

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University College of Medicine: lead

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bryan Chambers

  Drexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: April 17, 2017
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)