BIS-Guided Sedation Versus Standard Clinical Sedation During Elective Electrical Cardioversion for Atrial Fibrillation (BIS-ECV-RCT)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：AYLA ESIN
- 電話番号：+905326343959
- メール：ayla.esin@iuc.edu.tr
研究場所
-
-
-
Istanbul、トルコ（Türkiye）
- 募集
- Istanbul University-Cerrahpasa, Cardiology Institute
-
コンタクト：
- AYLA ESIN, MD
- 電話番号：00905326343959
- メール：ayla.esin@iuc.edu.tr
-
主任研究者：
- Kerem Erkalp, Professor MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
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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).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Recovery (Modified Aldrete Score ≥9)
時間枠：From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.
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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.
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From sedation induction to Modified Aldrete Score ≥9, assessed every 5 minutes post-ECV for up to 60 minutes.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Satisfaction
時間枠：Within 60 minutes post-procedure.
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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.
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Within 60 minutes post-procedure.
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Physician Satisfaction
時間枠：Immediately post-procedure (within 5 minutes of ECV completion).
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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.
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Immediately post-procedure (within 5 minutes of ECV completion).
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Procedural Pain
時間枠：Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).
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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.
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Within 60 minutes post-procedure (after Modified Aldrete Score ≥9).
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Cardioversion Success Rate
時間枠：Within 1 hour post-ECV.
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Proportion of patients achieving restoration of sinus rhythm confirmed by 12-lead ECG within 1 hour of the procedure.
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Within 1 hour post-ECV.
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Incidence of sedation related complications
時間枠：From sedation induction to 60 minutes post-procedure.
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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).
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From sedation induction to 60 minutes post-procedure.
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Number of Cardioversion Shocks and Total Energy Delivered
時間枠：During the ECV procedure.
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Total number of synchronized shocks delivered and cumulative energy (Joules) used per patient.
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During the ECV procedure.
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Total Anesthetic Drug Consumption
時間枠：During procedure
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Total dose (mg/kg) of propofol and fentanyl (µg/kg) administered during the procedure.
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During procedure
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協力者と研究者
捜査官
- 主任研究者：Kerem Erkalp, Professor Dr、Istanbul University - Cerrahpasa
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
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本研究に関する用語
キーワード
その他の研究ID番号
- 20260404
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