NCT04187196

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2020-04-29
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2019-12-05
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study