Fast-Track Anesthesia Using Dexmedetomidine and Ultrasound-Guided Erector Spinae Plane Block Versus Conventional Opioid-Based Anesthesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Tracheal Extubation
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) protocols have revolutionized perioperative management by implementing evidence-based, patient-centered strategies that improve clinical outcomes, shorten hospital length of stay, and reduce healthcare costs. In cardiac surgery, ERAS has facilitated the adoption of fast-track cardiac anesthesia (FTCA), which aims to achieve early extubation within 6-8 hours after surgery while maintaining patient safety. Compared with conventional high-dose opioid anesthesia, FTCA has been associated with shorter intensive care unit (ICU) stays, earlier mobilization, faster recovery, and comparable rates of mortality and major postoperative complications.
Despite these advantages, opioids remain the cornerstone of perioperative analgesia in cardiac surgery. Their use is associated with respiratory depression, delayed extubation, postoperative nausea and vomiting, ileus, urinary retention, delirium, opioid-induced hyperalgesia, and increased healthcare costs, highlighting the need for opioid-sparing anesthetic strategies.
Dexmedetomidine, a highly selective α2-adrenergic agonist, provides sedation, analgesia, and sympatholysis without clinically significant respiratory depression. In cardiac surgery, it improves hemodynamic stability, reduces perioperative opioid requirements, preserves spontaneous ventilation, and may decrease postoperative delirium, making it particularly suitable for fast-track extubation protocols.
Ultrasound-guided erector spinae plane block (ESPB) has emerged as a safe and effective regional analgesic technique. Compared with thoracic epidural and paravertebral blocks, ESPB offers a lower risk of complications, is technically straightforward, and provides effective bilateral analgesia for cardiac surgery. Randomized studies have demonstrated substantial reductions in intraoperative opioid consumption, improved postoperative pain control, and prolonged opioid-free analgesia.
Minimally invasive cardiac surgery (MICS), characterized by reduced surgical trauma and faster recovery compared with conventional sternotomy, provides an ideal setting to evaluate opioid-sparing anesthetic strategies. Combining dexmedetomidine with ultrasound-guided bilateral ESPB may optimize perioperative analgesia, facilitate early extubation, reduce opioid-related adverse effects, and enhance postoperative recovery, supporting ERAS principles in contemporary cardiac surgery.
详细描述
Enhanced Recovery After Surgery (ERAS) pathways have transformed perioperative care by implementing patient-centered, evidence-based protocols that improve outcomes while reducing hospital length of stay (HLOS) and healthcare expenditure [1]. In cardiac surgery, ERAS has driven the transition from conventional prolonged postoperative mechanical ventilation toward fast-track extubation (FTE) strategies [1,2].
Traditionally, cardiac anesthesia relied on high-dose opioid techniques (e.g., fentanyl 50-100 mcg/kg) combined with overnight ventilation to suppress surgical stress responses and maintain hemodynamic stability [2]. Although effective for these goals, this approach is associated with respiratory depression, delayed emergence, prolonged ICU stay, postoperative nausea and vomiting (PONV), ileus, delirium, and increased healthcare costs [1,3].
Fast-track cardiac anesthesia (FTCA) aims to achieve extubation within 6-8 hours after surgery, promoting earlier mobilization, faster oral intake, and reduced ICU-acquired weakness [1]. Evidence from a 2016 Cochrane review demonstrated that low-dose opioid FTCA provides comparable mortality, reintubation, and major complication rates to traditional high-dose regimens while significantly shortening ICU stay [2]. Modern protocols report successful extubation within 4-6 hours in more than 60% of elective cardiac surgery patients, with mean ICU stay around 31 hours [4].
Successful implementation of FTE depends on three core elements: (1) appropriate patient selection (EuroSCORE II <4%, LVEF ≥45%, absence of severe pulmonary disease), (2) optimized intraoperative management including reduced cardiopulmonary bypass (CPB) duration and careful inotrope use, and (3) structured postoperative weaning pathways [1].
Despite FTCA benefits, opioids remain the dominant perioperative analgesic strategy. High intraoperative opioid exposure suppresses respiratory drive, delaying extubation and increasing aspiration risk [2]. Postoperative opioid-related complications-including PONV (20-30% incidence), ileus, urinary retention, delirium, and pruritus-extend hospitalization and decrease patient satisfaction [1,3].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation. Randomization will be performed using a concealed allocation sequence. In the intervention group, patients will receive ultrasound-guided bilateral erector spinae plane block (ESPB) with dexmedetomidine-based fast-track anesthesia. To maintain participant blinding, patients in the control group will receive a sham subcutaneous saline injection after induction. The anesthesiologist performing the block and administering anesthesia will not be blinded because of the nature of the interventions. Data analysis will be performed using coded treatment assignments whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Scheduled for elective minimally invasive cardiac surgery (MICS), including:
- •Minimally invasive mitral valve repair or replacement. Minimally invasive aortic valve replacement. Atrial septal defect (ASD) closure. Minimally invasive direct coronary artery bypass (MIDCAB). Left ventricular ejection fraction (LVEF) ≥45%. EuroSCORE II <4%. American Society of Anesthesiologists (ASA) physical status II or III. Body mass index (BMI) 18-35 kg/m². Ability to understand the study procedures and provide written informed consent.
排除标准
- •Emergency cardiac surgery. BMI <18 or >35 kg/m². Severe pulmonary disease (COPD requiring home oxygen therapy or FEV1 <50% predicted).
- •Obstructive sleep apnea or anticipated difficult airway. Preoperative intubation, cardiogenic shock, or need for preoperative inotropic/vasopressor support.
- •Known allergy or contraindication to dexmedetomidine, fentanyl, bupivacaine, propofol, or other study medications.
- •Severe hepatic impairment or renal failure requiring dialysis (creatinine clearance <30 mL/min).
- •Chronic opioid use (>3 months) or chronic pain requiring long-term analgesics. Contraindications to erector spinae plane block (coagulopathy, platelet count <100,000/µL, INR >1.5, anticoagulant therapy, infection at the injection site, or patient refusal).
- •Baseline bradycardia (heart rate <50 beats/min) or second-/third-degree atrioventricular block without a functioning pacemaker.
- •Known substance abuse disorder
研究组 & 干预措施
Fast-Track Anesthesia (Dexmedetomidine + ESPB)
participants receive a fast-track anesthesia protocol consisting of intravenous dexmedetomidine combined with ultrasound-guided bilateral erector spinae plane block (ESPB), with opioid-sparing intraoperative anesthesia and standardized perioperative care.
干预措施: Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB) (Procedure)
Fast-Track Anesthesia (Dexmedetomidine + ESPB)
participants receive a fast-track anesthesia protocol consisting of intravenous dexmedetomidine combined with ultrasound-guided bilateral erector spinae plane block (ESPB), with opioid-sparing intraoperative anesthesia and standardized perioperative care.
干预措施: Dexmedetomidine (Drug)
conventional Opioid-Based Anesthesia
Participants receive conventional general anesthesia using fentanyl-based opioid analgesia according to the institutional standard protocol, together with standardized perioperative and postoperative care.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Time to Tracheal Extubation
时间窗: From ICU admission until successful extubation (within 48 hours postoperatively)
Time from arrival in the cardiothoracic intensive care unit (ICU) (connection to the ICU ventilator) until successful removal of the endotracheal tube. Successful extubation is defined as no requirement for reintubation
次要结局
- Postoperative Opioid Consumption(2, 6, 12, 24, and 48 hours after extubation.)
- Total Intraoperative Opioid Consumption(During surgery)
研究者
AbuElhassan Abdelrahman Rezk
assistant lecturer
Assiut University