Phase 4 N=73 Randomized Treatment

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

Atrial Fibrillation · Atrial Flutter

Bottom Line

View on ClinicalTrials.gov: NCT04187196 ↗

Enrolled (actual)

Serious AEs

1.4%

Results posted

Nov 2023

Primary outcome: Primary: Time From Initiation of Sedation to Full Recovery — 7.6; 5.5 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Propofol (Drug); Methohexital (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Initiation of Sedation to Full Recovery	7.6; 5.5	—
SECONDARY Time From End of Injection to Loss of Conscious	1.0; 1.0	—
SECONDARY Time to First Electrical Direct-current Shock	1.28; 1.2	—
SECONDARY Time to Eyes Opening	7.0; 4.2	—
SECONDARY Systolic Blood Pressure	132; 140; 138; 144; 124; 132	—
SECONDARY Diastolic Blood Pressure	78; 79.5; 82; 81.5; 70; 76	—
SECONDARY Mean Arterial Blood Pressure	104; 104.5; 102; 104.5; 91; 101.5	—
SECONDARY Respiratory Rate	16; 16.5; 18; 16.5; 17; 17	—
SECONDARY Saturation of Peripheral Oxygen (SpO2)	100; 100; 100; 100; 98; 99.5	—
SECONDARY Heart Rate	96; 93; 100; 92; 69; 73.5	—
SECONDARY Recall of Pain at Injection Site - Visual Analog Scale	8; 2	—
SECONDARY Recall of Anything Unpleasant About the Procedure - Visual Analog Scale	3; 1	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04187196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.