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Study identifier: NCT07569016 Synced from ClinicalTrials.gov · July 29, 2026
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BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation

Condition: Atrial Fibrillation · Electric Countershock · Deep Sedation  ·  Sponsor: Istanbul University - Cerrahpasa

PhaseNA
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Electrical cardioversion (ECV) is a standard procedure used to restore normal heart rhythm in patients with atrial fibrillation (AF) by delivering a brief electrical shock to the heart. Because the procedure is painful and distressing, patients receive sedation - a controlled state of reduced consciousness - using short-acting intravenous medications. However, the optimal depth of sedation for ECV has not been well defined: too deep may cause breathing problems and low blood pressure, while too light may result in pain, awareness, or patient movement during the shock. Bispectral index (BIS) monitoring is a non-invasive technology that continuously measures brain activity using an EEG sensor placed on the forehead, generating a numerical score from 0 (no brain activity) to 100 (fully awake). BIS scores between 61 and 80 correspond to moderate sedation, which preliminary observations suggest may be sufficient for ECV without the risks associated with deeper sedation. This randomized controlled trial will compare two approaches to sedation monitoring during elective ECV for AF: * Group 1 (BIS Group): Sedation is guided by BIS monitoring, targeting a score of 61-80. * Group 2 (Control Group): Sedation is guided by standard clinical assessment (loss of response to verbal commands and eyelash reflex), with BIS recorded but not visible to the treating team. Both groups will receive the same medications (propofol and fentanyl). The primary outcome is how quickly patients recover …

This description comes directly from the study's public registry record.

Talk to the study team

AYLA ESIN  ·  +905326343959  ·  ayla.esin@iuc.edu.tr

Always discuss trial participation with your own doctor first.

Locations (1)

Istanbul University-Cerrahpasa, Cardiology InstituteIstanbul, Turkey (Türkiye)Recruiting

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Source record: clinicaltrials.gov/study/NCT07569016