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

NCT07569016 | Not Yet Recruiting

• 1 other identifier: 20260404
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Electric Countershock; Deep Sedation

Keywords

atrial fibrillation; Electric Countershock; sedation; bispectral index; propofol; anesthesia recovery

Outcome Measures

Primary Outcomes (1)

• Time to Recovery (Modified Aldrete Score ≥9)

  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.

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

Secondary Outcomes (7)

• Patient Satisfaction

  Within 60 minutes post-procedure.

• Physician Satisfaction

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

• Procedural Pain

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

• Cardioversion Success Rate

  Within 1 hour post-ECV.

• Incidence of sedation related complications

  From sedation induction to 60 minutes post-procedure.

Study Arms (2)

BIS-Guided Sedation (BIS Group)

EXPERIMENTAL

Patients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by continuous BIS monitoring, targeting a BIS range of 61-80. Cardioversion is initiated once the target BIS range is achieved and clinical endpoints (loss of verbal contact, loss of eyelash reflex) are confirmed.

Drug: BIS-guided propofol sedation

Standard Clinical Sedation (Control Group)

ACTIVE COMPARATOR

Patients in this group receive sedation with intravenous fentanyl (0.5-1 µg/kg) followed by titrated propofol (0.5-1 mg/kg) guided by standard clinical assessment (loss of verbal contact, loss of eyelash reflex). BIS monitoring is applied but the monitor screen is physically concealed from the treating team. BIS values are recorded for analysis only.

Drug: Clinical-guided propofol sedation

Interventions

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).

Standard Clinical Sedation (Control Group)

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.

BIS-Guided Sedation (BIS Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cardiology Institute

Istanbul, İ̇stanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerem Erkalp, Professor Dr

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYLA ESIN

CONTACT

+905326343959; ayla.esin@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 6, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)