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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Drug: Methohexital; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04187196

IRB00061732

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Sedation with propofol group

Experimental group

Description:

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

Treatment:

Drug: Propofol

Sedation with methohexital group

Experimental group

Description:

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

Treatment:

Drug: Methohexital