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BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation

RecruitingNAAges 18 Years - anyAllIstanbul University - Cerrahpasa
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In plain words

What the trial is, and whether it could suit you

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 sugg

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Documented atrial fibrillation with indication for elective electrical cardioversion * American Society of Anesthesiologists (ASA) physical status class I, II, or III * Left ventricular ejection fraction ≥30% on echocardiography * Adequate anticoagulation: INR ≥2.0, OR ≥3 weeks of therapeutic anticoagulation, OR absence of left atrial thrombus confirmed by transesophageal echocardiography * Ability and willingness to provide written informed consent Exclusion Criteria: * Known allergy or contraindication to propofol or fentanyl, or their excipients (soy, egg) * Hemodynamic instability (systolic blood pressure \<90 mmHg or symptomatic hypotension) * Decompensated heart failure (NYHA functional class IV) * Severe obstructive sleep apnea requiring CPAP or BiPAP therapy * Anticipated difficult airway (modified Mallampati classification class III or IV) * Baseline oxygen saturation \<94% or active chronic obstructive pulmonary disease * Severe hepatic impairment (transaminases \>3× upper limit of normal) or severe renal impairment (eGFR \<30 mL/min/1.73m²) * Active psychiatric illness or cognitive impairment precluding questionnaire completion * Pregnancy or breastfeeding * Alcohol or substance use within the preceding 24 hours * Prior participation in this trial
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What it tests

  • BIS-guided propofol sedation
  • Clinical-guided propofol sedation
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Where

1 site
Istanbul University-Cerrahpasa, Cardiology Institute
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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