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NCT Number: NCT07569016

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

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 after the procedure, measured by the Modified Aldrete Score - a standard clinical recovery assessment tool. Secondary outcomes include patient and physician satisfaction, procedural pain, risk of awareness during the procedure, cardioversion success rate, hemodynamic stability, and complication rates.

The trial will enroll 60 adult patients at Istanbul University-Cerrahpasa Cardiology Institute. Findings are expected to provide evidence-based guidance for standardizing sedation protocols during ECV.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Deep Sedation Electric Countershock Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cardiology Institute

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

AYLA ESIN, MD

CONTACT

[email protected]

00905326343959

Kerem Erkalp, Professor MD

PRINCIPAL_INVESTIGATOR

About this study

Background:

Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia. Elective electrical cardioversion (ECV) is a widely used rhythm control strategy. Procedural sedation is a critical component of ECV; however, the optimal monitoring method and depth of sedation remain undefined. Excessive sedation risks respiratory depression and hemodynamic instability, particularly in patients with structural heart disease, while inadequate sedation may result in patient movement, pain, and procedural awareness.

Bispectral index (BIS) monitoring offers objective, real-time quantification of sedation depth. Preliminary clinical observation at our center suggests that BIS 61-80 provides adequate procedural conditions for ECV with propofol-fentanyl sedation, while deeper sedation (BIS <60) is associated with increased respiratory depression without additional procedural benefit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS-guided propofol sedation

Drug

IV propofol 0.5-1 mg/kg titrated to BIS 61-80, preceded by IV fentanyl 0.5-1 µg/kg. Additional propofol 0.25-0.5 mg/kg boluses as needed for repeat shocks within target range.

Clinical-guided propofol sedation

Drug

IV propofol 0.5-1 mg/kg titrated to clinical endpoints, preceded by IV fentanyl 0.5-1 µg/kg. BIS recording passive (blinded to operator).

Primary outcomes

  1. Time to Recovery (Modified Aldrete Score ≥9)

    Time frame: From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.

    Time in minutes from sedation induction (first propofol dose) to achievement of Modified Aldrete Score ≥9, assessed by an independent, blinded anesthesiologist. The Modified Aldrete Score evaluates activity, respiration, circulation, consciousness, and oxygen saturation (0-2 points each; maximum 10). Score ≥9 indicates readiness for discharge from monitored care.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Within 60 minutes post-procedure.

    Patient-reported global satisfaction with the procedure assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied), administered by the blinded assessor after Modified Aldrete Score ≥9 is achieved.

  2. Physician Satisfaction

    Time frame: Immediately post-procedure (within 5 minutes of ECV completion).

    Treating cardiologist's global satisfaction with sedation conditions assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied), recorded immediately after the procedure.

  3. Procedural Pain

    Time frame: Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).

    Patient-reported pain intensity during the procedure assessed using the Numeric Rating Scale-11 (NRS-11; 0 = no pain, 10 = worst imaginable pain), administered after recovery.

  4. Cardioversion Success Rate

    Time frame: Within 1 hour post-ECV.

    Proportion of patients achieving restoration of sinus rhythm confirmed by 12-lead ECG within 1 hour of the procedure.

  5. Incidence of sedation related complications

    Time frame: From sedation induction to 60 minutes post-procedure.

    Proportion of patients experiencing any of the following: hypotension (systolic BP <90 mmHg), bradycardia (HR <50 bpm), oxygen desaturation (SpO₂ <90%), apnea, laryngospasm, or procedurally significant arrhythmia. Recorded as a composite binary outcome (yes/no).

  6. Total Anesthetic Drug Consumption

    Time frame: During procedure

    Total dose (mg/kg) of propofol and fentanyl (µg/kg) administered during the procedure.

  7. Number of Cardioversion Shocks and Total Energy Delivered

    Time frame: During the ECV procedure.

    Total number of synchronized shocks delivered and cumulative energy (Joules) used per patient.

Study contacts

Contact information is provided by the study sponsor or research team.

AYLA ESIN

CONTACT

[email protected]

+905326343959

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Bispectral Index-Guided Sedation Versus Standard Clinical Assessment-Guided Sedation During Elective Electrical Cardioversion for Atrial Fibrillation: A Prospective, Single-Center, Randomized Controlled, Assessor-Blinded Trial

Acronym: BIS-ECV-RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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