Clinical trial NCT04187196: Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Official title: Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Cardioversion
Propofol
Deep sedation
Intravenous anesthetics
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Time From Initiation of Sedation to Full Recovery
timeFrame: Day 1
Secondary outcomes:
measure: Time From End of Injection to Loss of Conscious
timeFrame: Day 1
measure: Time to First Electrical Direct-current Shock
timeFrame: Day 1
measure: Time to Eyes Opening
timeFrame: Day 1
measure: Systolic Blood Pressure
timeFrame: 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
measure: Diastolic Blood Pressure
timeFrame: 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
measure: Mean Arterial Blood Pressure
timeFrame: 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
measure: Respiratory Rate
timeFrame: 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
measure: Saturation of Peripheral Oxygen (SpO2)
timeFrame: 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
measure: Heart Rate
timeFrame: 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
measure: Recall of Pain at Injection Site - Visual Analog Scale
timeFrame: Day 1
measure: Recall of Anything Unpleasant About the Procedure - Visual Analog Scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Elijah Beaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaty EH, Fernando RJ, Jacobs ML, Winter GG, Bulla C, Singleton MJ, Patel NJ, Bradford NS, Bhave PD, Royster RL. Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion. J Am Heart Assoc. 2022 Oct 4;11(19):e026198. doi: 10.1161/JAHA.122.026198. Epub 2022 Sep 21.