Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01901575
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 21
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin

Condition or Disease	Intervention/Treatment	Phase
Tachycardia, Ventricular	Drug: Remifentanil	Phase 4

Detailed Description

The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped.

You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remifentanil IV PCA for Ablation of Idiopathic Ventricular Tachycardia
• Actual Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remifentanil IV PCA patients with PVC's prior to administration of remifentanil	Drug: Remifentanil; Patients with established PVC's , sedated with remifentanil IVPCA per study protocol; Other Names: Ultiva

Outcome Measures

Primary Outcome Measures

1. Inhibition of Idiopathic Ventricular Tachycardia [duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours]

   observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's. Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation.

2. PVC Suppression With Remifentanil Sedation [duration of the operative procedure, average 2 hours]

   1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin

• Patients between 18 and 65

• ASA 1-3

Exclusion Criteria:

• ASA 4 and 5

• Age 18 and 65

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Misha Kogan, MD, NYU School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Garofalo NA, Teixeira-Neto FJ, Schwartz DS, Vailati Mdo C, Steagall PV. Effects of the opioid remifentanil on the arrhythmogenicity of epinephrine in halothane-anesthetized dogs. Can J Vet Res. 2008 Jul;72(4):362-6.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01901575
• Other Study ID Numbers: 11-00800
• First Posted: Jul 17, 2013
• Last Update Posted: Jan 2, 2018
• Last Verified: Dec 1, 2017

• 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.: No
• Keywords provided by NYU Langone Health: idiopathic ventricular tachycardia
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Remifentanil

Study Results

Participant Flow

Arm/Group Title	Remifentanil IV PCA
Arm/Group Description	Patients with established PVC's sedated with remifentanil IVPCA per study protocol
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Remifentanil
Arm/Group Description	Remifentanil IV PCA
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	9 56.3%
Male	7 43.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 12.5%
White	12 75%
More than one race	0 0%
Unknown or Not Reported	2 12.5%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Inhibition of Idiopathic Ventricular Tachycardia
Description	observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's. Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation.
Time Frame	duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours

Outcome Measure Data

Analysis Population Description

Study Data impacted by Storm Sandy in NYC and data lost for reporting

Arm/Group Title	Remifentanil IV PCA
Arm/Group Description	Patients with established PVC's sedated with remifentanil IVPCA per study protocol
Measure Participants	0

2. Primary Outcome

Title	PVC Suppression With Remifentanil Sedation
Description	1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression
Time Frame	duration of the operative procedure, average 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil IV PCA
Arm/Group Description	patients with PVC's prior to administration of remifentanil Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Measure Participants	16
Number [participants with PVC suppression]	2 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil IV PCA
	Comments	null hypothesis: Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 0.15%; 0.65 to 0.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	Serious and/or Other [non-serious] Adverse Events were not collected/assessed. Clinical sedation was provided in accordance with the standard of care adopted by the American Society of Anesthesiologists and approved by the medical center. Patients participating in the study were not at any additional risk.
Arm/Group Title	Remifentanil IV PCA
Arm/Group Description	Patients with established PVC's sedated with remifentanil IVPCA per study protocol
All Cause Mortality
	Remifentanil IV PCA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Remifentanil IV PCA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Remifentanil IV PCA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.