Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
- Conditions
- Atrial FlutterAtrial Fibrillation
- Interventions
- Registration Number
- NCT04187196
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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:
1. 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.
2. 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:
1. There will be no significant increase in adverse events associated with the use of methohexital when compared with propofol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sedation with methohexital group Methohexital Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion. Sedation with propofol group Propofol Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.
- Primary Outcome Measures
Name Time Method Time From Initiation of Sedation to Full Recovery 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.
- Secondary Outcome Measures
Name Time Method 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 Recorded in seconds.
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 These are 100 mm lines that are anchored with "no pain" on one end and "worst imaginable pain" on the other end. Total range 0-100, higher numbers correspond to worse pain.
Recall of Anything Unpleasant About the Procedure - Visual Analog Scale Day 1 These are 100 mm lines that are anchored with "no distress" on one end and "worst imaginable distress" on the other end. Total range 0-100, higher numbers correspond to worse distress.
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 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 Recorded in minutes.
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 Time to Eyes Opening Day 1 Recorded in seconds.
Trial Locations
- Locations (1)
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States