Anesthetic Techniques in EP Patients

Cardiac Disease Clinical Trial

Official title:

Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02664922
• Other study ID #: Anes Tech 11-003514
• Status: Terminated
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare different combinations of anesthetic drugs (cause loss of sensation) in terms of effectiveness, adverse effects, pain relief, and patient comfort for cardiac electrophysiology procedures. In addition, the investigators are studying the different anesthetic combinations to determine the best approach in terms of identification and treatment of arrhythmias.

Description:

Anesthetic management in patients coming for electrophysiology procedures is extremely important and hemodynamically challenging in order to minimize interference on the electrophysiology studies (EPS) and the ability to trigger arrhythmias while also maintaining patient comfort and limited movement. Various anesthetic combinations are administered to provide sedation, analgesia/sedation, or general anesthesia. The ideal agent should produce rapid loss of consciousness while ensuring cardiovascular stability and prompt recovery with few adverse effects. Our goal is to study anesthetic techniques and the effect on electrophysiology procedures to determine the best anesthetic combination in terms of effectiveness, adverse effects, pain relief, and patient comfort.

Adult patients scheduled for electrophysiology procedures will be enrolled in the study and randomly assigned to an anesthetic group based on their schedule procedure. Sedation cases for supraventricular tachycardia (SVT), right ventricular outflow tract (RVOT)/premature ventricular contraction (PVC) ablation, and atrial flutter (aflutter) procedures will be randomly assigned to one of three groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep), or 3) monitored anesthesia with remifentanil infusion (pain reliever) + propofol (induce sleep). Sedation cases for ventricular tachycardia (VT) ablation and atrial fibrillation (afib) procedures will be randomly assigned to one of two groups: 1) monitored anesthesia (local anesthesia with sedation and analgesia/pain reliever) with propofol (induce sleep), or 2) monitored anesthesia with ketamine (sedation) + propofol (induce sleep). General anesthesia (GA) cases, including VT ablation and afib procedures will receive general anesthesia (state of unconsciousness) with sevoflurane (loss of consciousness) + O2. Anesthesia factors, such as hemodynamics and cerebral oxygen saturation will be continuously monitored and recorded throughout the study. In addition, we will be looking at standard echocardiogram and electrophysiology (EP) parameters. The patient's pain level, level of sedation, and satisfaction will also be measured using scales, assessments, and surveys.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for cardiac electrophysiology procedures

• Patients =18 years of age

Exclusion Criteria:

• Gastroesophageal reflux disease (GERD),

• pulmonary hypertension,

• severe pulmonary disease,

• obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• Propofol
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
• Ketamine
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures. 1 of 2 sedation groups for VT ablation and afib procedures.
• Remifentanil
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
• Sevoflurane
1 general anesthesia group for VT ablations and afib procedures.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.	Direct observation and medical record review will be used to analyze adverse effects. Reported as number of participants with one or more adverse events.	Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Primary	Effectiveness of Anesthetic Drugs in Terms of Pain Relief.	A patient's pain level will be assessed using a numerical pain rating scale from 0 "no pain" to 10 "worst possible pain".	Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Primary	Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.	A patient's level of sedation will be assessed using a scoring system on a scale from 1-5. The Observer's Assessment of Alertness/Sedation (OAA/S) Score Responsiveness Component score from 1 - Does not respond to mild prodding or shaking to 5 - Responds readily to name spoken in normal tone.	Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Primary	Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.	Patients will also be asked to complete a written questionnaire prior to discharge from the hospital to measure patient satisfaction during their anesthesia care. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much.	Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Secondary	Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.	The proceduralist will complete a written questionnaire after the procedure to rate their satisfaction. A Likert Scale is used and ranges from 1 - Disagree very much to 6 - Agree very much.	Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.
Secondary	Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.	The proceduralist will follow-up 1-3 months post-procedure to evaluate the number of participants with clinical success reported by number of recurrences. Clinical success is defined as 0 recurrences in participants at 1-3 months post-operatively.	1-3 months postoperatively