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BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation (BIS-ECV-RCT)

12 de maio de 2026 atualizado por: AYLA ESİN, Istanbul University - Cerrahpasa

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Turquia (Türkiye)
      • Istanbul, Turquia (Türkiye)
        • Recrutamento
        • Istanbul University-Cerrahpasa, Cardiology Institute
        • Contato:
        • Investigador principal:
          • Kerem Erkalp, Professor MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BIS-Guided Sedation (BIS Group)
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.
Medicamento: BIS-guided propofol sedation
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.
Comparador Ativo: Standard Clinical Sedation (Control Group)
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.
Medicamento: Clinical-guided propofol sedation
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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to Recovery (Modified Aldrete Score ≥9)
Prazo: 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.
From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient Satisfaction
Prazo: 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.
Within 60 minutes post-procedure.
Physician Satisfaction
Prazo: 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.
Immediately post-procedure (within 5 minutes of ECV completion).
Procedural Pain
Prazo: 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.
Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).
Cardioversion Success Rate
Prazo: Within 1 hour post-ECV.
Proportion of patients achieving restoration of sinus rhythm confirmed by 12-lead ECG within 1 hour of the procedure.
Within 1 hour post-ECV.
Incidence of sedation related complications
Prazo: 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).
From sedation induction to 60 minutes post-procedure.
Number of Cardioversion Shocks and Total Energy Delivered
Prazo: During the ECV procedure.
Total number of synchronized shocks delivered and cumulative energy (Joules) used per patient.
During the ECV procedure.
Total Anesthetic Drug Consumption
Prazo: During procedure
Total dose (mg/kg) of propofol and fentanyl (µg/kg) administered during the procedure.
During procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Istanbul University - Cerrahpasa

Investigadores

  • Investigador principal: Kerem Erkalp, Professor Dr, Istanbul University - Cerrahpasa

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de abril de 2026

Conclusão Primária (Estimado)

15 de junho de 2026

Conclusão do estudo (Estimado)

15 de julho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de maio de 2026

Primeira postagem (Real)

6 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20260404

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared publicly. Aggregate de-identified results will be reported in peer-reviewed publications.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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