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Trial record 5 of 32 for:    mahajan

Anesthetic Techniques in EP Patients

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ClinicalTrials.gov Identifier: NCT02664922
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Aman Mahajan, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Drug: Propofol Drug: Ketamine Drug: Remifentanil Drug: Sevoflurane Phase 4

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures
Actual Study Start Date : May 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Sedation - Group 1
Sedation - monitored anesthesia with propofol.
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.

Other Name: Diprivan

Experimental: Sedation - Group 2
Sedation - monitored anesthesia with ketamine + propofol
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.

Other Name: Diprivan

Drug: 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.

Other Name: Ketalar

Experimental: Sedation - Group 3
Sedation - monitored anesthesia with remifentanil + propofol
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.

Other Name: Diprivan

Drug: Remifentanil
1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
Other Name: Ultiva

Experimental: General Anesthesia - Group 1
General anesthesia (GA) with Sevoflurane + O2
Drug: Sevoflurane
1 general anesthesia group for VT ablations and afib procedures.
Other Name: Ultane




Primary Outcome Measures :
  1. Effectiveness of anesthetic drugs in terms of adverse effects. [ Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. ]
    Direct observation and medical record review will be used to analyze adverse effects.

  2. Effectiveness of anesthetic drugs in terms of pain relief. [ Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. ]
    A patient's pain level will be assessed using a numerical pain rating scale.

  3. Effectiveness of anesthetic drugs in terms of patient comfort and satisfaction. [ Time Frame: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours. ]
    A patient's level of sedation will be assessed using a scoring system on a scale from 1-5. Patients will also be asked to complete a written questionnaire prior to discharge from the hospital to measure patient satisfaction during their anesthesia care.


Secondary Outcome Measures :
  1. Effectiveness of anesthetic drugs in terms of identification and treatment of arrhythmias. [ Time Frame: Intraoperatively to 3 months postoperatively ]
    The proceduralist will also complete a written questionnaire after the procedure to rate their satisfaction and follow-up 1-3 months post-procedure to evaluate clinical success.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664922


Locations
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Aman Mahajan, MD, PhD University of California, Los Angeles

Responsible Party: Aman Mahajan, Chair & Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02664922     History of Changes
Other Study ID Numbers: Anes Tech 11-003514
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aman Mahajan, University of California, Los Angeles:
Electrophysiology
Anesthetics

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Anesthetics
Propofol
Ketamine
Remifentanil
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation