Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2022-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sedation with propofol group

Participants in this group will be randomized to sedation with bolus dosing of propofol for cardioversion.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved

Sedation with methohexital group

Participants in this group will be randomized to sedation with bolus dosing of methohexital for cardioversion.

Group Type EXPERIMENTAL

Methohexital

Intervention Type DRUG

Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved

Interventions

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Propofol

Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved

Intervention Type DRUG

Methohexital

Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved

Intervention Type DRUG

Other Intervention Names

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Diprivan Brevital Brietal

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No