Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Time From Initiation of Sedation to Full Recovery
研究概览
简要总结
A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct current cardioversion (DCCV) when using methohexital when compared to the more often used propofol.
详细描述
The investigators theorize that the use of methohexital during cardioversion will result in a shorter time to effective sedation and time to full recovery when compared to the use of propofol. This will change how sedation is approached for elective cardioversions.
Primary Hypothesis:
- The mean time to recovery from sedation during a cardioversion using methohexital for sedation will be significantly shorter than the recovery time using propofol for sedation, as evidenced by a short time from initiation of induction to a score of 2 on the Ramsay Sedation Scale.
- The mean time to a Ramsay score of 5-6 will be significantly shorter using methohexital than the time to the same sedation level using propofol
Secondary Hypothesis:
- There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who present to Wake Forest Baptist Medical Center for a direct current cardioversion for treatment of paroxysmal or persistent atrial fibrillation as well as atrial flutter.
排除标准
- •Patients with sedation for transesophageal echocardiogram within 30 minutes of DCCV
- •Hemodynamically compromised patients (as defined by hypotension <90/50 mmHg, altered mental status, shock, ischemic chest discomfort, or heart failure)
研究组 & 干预措施
Sedation with propofol group
Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
干预措施: Propofol (Drug)
Sedation with methohexital group
Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.
干预措施: Methohexital (Drug)
结局指标
主要结局
Time From Initiation of Sedation to Full Recovery
时间窗: Day 1
The time from initiation of sedation to full recovery Ramsay Sedation Scale (RSS) of 2 (RSS 2 means awake; cooperative, oriented, and tranquil.)-- as evidenced by the ability to answer the questions "What is your name and what is your age?" The timer will start at the initiation of induction. Recorded in minutes.
次要结局
- Diastolic Blood Pressure(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)
- Time From End of Injection to Loss of Conscious(Day 1)
- Systolic Blood Pressure(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)
- Respiratory Rate(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)
- Mean Arterial Blood Pressure(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)
- Time to First Electrical Direct-current Shock(Day 1)
- Recall of Anything Unpleasant About the Procedure - Visual Analog Scale(Day 1)
- Time to Eyes Opening(Day 1)
- Heart Rate(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)
- Recall of Pain at Injection Site - Visual Analog Scale(Day 1)
- Saturation of Peripheral Oxygen (SpO2)(Day 1: at induction, prior to first shock, and 1 minute, 3 minutes, 5 minutes, 7 minutes, 9 minutes, 10 minutes, 15 minutes, 20 minutes and 30 minutes after first cardioversion)