Trial Outcomes & Findings for Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia (NCT NCT01901575)

NCT ID: NCT01901575

Last Updated: 2018-01-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 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
• Results posted on: 2018-01-02

Participant Flow

Participant milestones

Measure	Remifentanil IV PCA Patients with established PVC's sedated with remifentanil IVPCA per study protocol
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Remifentanil n=16 Participants Remifentanil IV PCA
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	16 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Remifentanil IV PCA n=16 Participants Patients with established PVC's sedated with remifentanil IVPCA per study protocol
PVC Suppression With Remifentanil Sedation	2 participants with PVC suppression

Adverse Events

Remifentanil IV PCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Avrimin M. Kogan, MD

NYU Langone Medical Center

Phone: (212) 263-5072

Email: Avrimin.Kogan@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place