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临床试验/NCT02664922
NCT02664922终止4 期

Anesthetic Techniques and the Effect on Cardiac Electrophysiology Procedures

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
35
试验地点
1
主要终点
Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for cardiac electrophysiology procedures
  • Patients ≥18 years of age

排除标准

  • Gastroesophageal reflux disease (GERD),
  • pulmonary hypertension,
  • severe pulmonary disease,
  • obstructive sleep apnea (OSA) with continuous positive airway pressure therapy (CPAP)

研究组 & 干预措施

Sedation - Group 1

Experimental

Sedation - monitored anesthesia with propofol.

干预措施: Propofol (Drug)

Sedation - Group 2

Experimental

Sedation - monitored anesthesia with ketamine + propofol

干预措施: Propofol (Drug)

Sedation - Group 2

Experimental

Sedation - monitored anesthesia with ketamine + propofol

干预措施: Ketamine (Drug)

Sedation - Group 3

Experimental

Sedation - monitored anesthesia with remifentanil + propofol

干预措施: Propofol (Drug)

Sedation - Group 3

Experimental

Sedation - monitored anesthesia with remifentanil + propofol

干预措施: Remifentanil (Drug)

General Anesthesia - Group 1

Experimental

General anesthesia (GA) with Sevoflurane + O2

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Effectiveness of Anesthetic Drugs in Terms of Patient Satisfaction.

时间窗: Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.

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.

Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Adverse Events.

时间窗: 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. Reported as number of participants with one or more adverse events.

Effectiveness of Anesthetic Drugs in Terms of Pain Relief.

时间窗: 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 from 0 "no pain" to 10 "worst possible pain".

Effectiveness of Anesthetic Drugs in Terms of Patient Comfort.

时间窗: 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. 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.

次要结局

  • Effectiveness of Anesthetic Drugs in Terms of Number of Participants With Clinical Success.(1-3 months postoperatively)
  • Effectiveness of Anesthetic Drugs in Terms of Proceduralist Satisfaction.(Intraoperatively to postoperatively in the ICU, an expected average of 5-7 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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