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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to Recovery (Modified Aldrete Score ≥9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Clinical-guided propofol sedation (Drug)
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.
干预措施: BIS-guided propofol sedation (Drug)
结局指标
主要结局
Time to Recovery (Modified Aldrete Score ≥9)
时间窗: 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.
次要结局
- 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.)
- Total Anesthetic Drug Consumption(From sedation induction to procedure completion.)
- Number of Cardioversion Shocks and Total Energy Delivered(During the ECV procedure.)
研究者
AYLA ESİN
medical doctor
Istanbul University - Cerrahpasa