BIS-guided sedation for electrical cardioversion in atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study compares BIS-guided propofol-fentanyl sedation with standard clinician-guided sedation during elective electrical cardioversion for atrial fibrillation. The goal is to determine if objective BIS monitoring can maintain adequate procedural conditions while reducing sedation depth-related risks such as respiratory depression and hemodynamic instability. Eligible adults with AF, good heart function, and adequate anticoagulation are enrolled and randomized to either BIS-guided or clinician-guided sedation. Outcomes focus on sedation depth, respiratory events, hemodynamics, pain control, and patient/mare clinician satisfaction. The investigation uses continuous BIS monitoring to target a moderate sedation range (roughly BIS 61-80) during the procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Istanbul University-Cerrahpasa, Cardiology Institute
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Kerem Erkalp, Professor Dr — Istanbul University - Cerrahpasa
• Study coordinator: Ayla Esin
• Email: ayla.esin@iuc.edu.tr
• Phone: +905326343959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.