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Набор скоро начнётся NCT07749274

Fast-Track Anesthesia in Minimally Invasive Cardiac Surgery: Dexmedetomidine and Erector Spinae Plane Block vs Opioid-Based Anesthesia

Без фазы С лечением Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative Pain

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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dexmedetomidine, Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB), Fentanyl.
Кому может быть актуально
Состояния в реестре: Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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Официальное название

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

Обзор

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.

Подробное описание

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 \[1,3\].

Additional concerns include opioid-induced immunosuppression potentially increasing infection risk after CPB and opioid-induced hyperalgesia and tolerance complicating postoperative analgesia, especially in opioid-naïve patients \[6\]. These concerns, together with the ongoing opioid epidemic, reinforce the need to minimize perioperative opioid exposure in alignment with ERAS principles \[1\].

Dexmedetomidine is a highly selective α2-adrenergic agonist (α2:α1 selectivity ratio 1620:1) providing sedation, anxiolysis, and analgesia without clinically significant respiratory depression \[3\].

In cardiac surgery, dexmedetomidine offers several advantages:

* Hemodynamic stability: attenuates sympathoadrenal responses during laryngoscopy and intubation without tachycardia; a preoperative dose of 0.5 mcg/kg effectively reduces heart rate and blood pressure surges \[3\]. * Myocardial protection: lowers myocardial oxygen consumption and may reduce postoperative troponin release compared with propofol-based anesthesia. * Delirium prevention: associated with reduced postoperative delirium incidence, particularly relevant because prolonged ventilation independently increases delirium risk. * Opioid-sparing effect: decreases perioperative opioid requirements by approximately 30-50% \[3\].

Importantly, preservation of respiratory drive makes dexmedetomidine particularly suitable for FTCA protocols where early extubation is a primary objective \[3\].

Introduced by Forero et al. in 2016 for thoracic neuropathic pain, ESPB has emerged as a simple, safe, and effective fascial plane block \[5\]. Local anesthetic injected between the transverse process and erector spinae muscle spreads craniocaudally, reaching dorsal and ventral spinal nerve rami from T1-T12 \[1\].

Compared with thoracic epidural or paravertebral approaches, ESPB provides several advantages in cardiac surgery:

* Improved safety: minimal risk of spinal hematoma in anticoagulated patients, lower pneumothorax risk, and avoidance of sympathectomy-related hypotension \[6\]. * Technical simplicity: ultrasound guidance permits real-time identification of anatomical landmarks while avoiding neural and vascular structures \[6\]. * Bilateral applicability: suitable for median sternotomy and minimally invasive cardiac surgery (MICS) requiring bilateral analgesia \[7\].

Clinical evidence supports its analgesic efficacy. A randomized study in minimally invasive coronary artery bypass grafting (MIDCAB) demonstrated a 70% reduction in intraoperative fentanyl use (0.9 mg vs. 3.0 mg; p\<0.01), reduced norepinephrine requirements, and prolonged opioid-free analgesia for 34 hours postoperatively \[8\]. Additional randomized evidence in MICS confirmed lower postoperative opioid consumption and improved pain control compared with local infiltration techniques \[9\].

Combining dexmedetomidine with local anesthetics may extend block duration through two complementary mechanisms:

1. Local vasoconstriction: reducing anesthetic washout from the injection site. 2. Direct analgesic action: activation of peripheral and dorsal root ganglion α2 receptors, suppressing nociceptive transmission \[7\].

A current randomized study (NCT06981949) is evaluating whether bilateral ESPB using dexmedetomidine (0.5 mcg/kg per side) with ropivacaine 0.375% prolongs analgesia and further reduces opioid requirements compared with ropivacaine alone \[7\].

MICS includes procedures performed through limited-access approaches such as mini-thoracotomy, mini-sternotomy, or port-access techniques instead of full median sternotomy. Compared with conventional cardiac surgery, MICS reduces tissue trauma, postoperative pain, recovery time, and hospitalization duration \[1,8\]. Nevertheless, effective analgesia remains challenging because of chest tubes, rib retraction, and pleurotomy.

Because MICS patients generally have lower operative risk (lower EuroSCORE), reduced tissue injury, and fewer contraindications to ESPB, this population represents an ideal setting to evaluate a combined dexmedetomidine-ESPB opioid-sparing fast-track extubation strategy \[9\].

Вмешательства

  • Препарат Dexmedetomidine
    Intravenous dexmedetomidine administered as part of a fast-track anesthesia protocol. Patients receive a loading dose of 0.5-1.0 µg/kg over 10 minutes before intubation, followed by an intraoperative infusion of 0.2-0.7 µg/kg/h, adjusted according to hemodynamic response. During cardiopulmonary bypass, the infusion is reduced to 0.2 µg/kg/h. Rescue fentanyl (0.5 µg/kg IV) is permitted only if predefined hemodynamic criteria are met.
  • Процедура Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB)
    Ultrasound-guided bilateral erector spinae plane block performed after induction of anesthesia and before surgical incision. A total of 20 mL of 0.25% bupivacaine is injected into the erector spinae plane on each side at the T5 level using an in-plane ultrasound-guided technique. The procedure is performed as part of an opioid-sparing multimodal analgesia strategy.
  • Препарат Fentanyl
    Conventional opioid-based general anesthesia using intravenous fentanyl. A dose of 5 µg/kg is administered during induction followed by an intraoperative infusion of 1-3 µg/kg/h, titrated according to hemodynamic parameters and institutional practice. Standardized perioperative management is otherwise identical to the experimental group.

Первичные конечные точки

  • Time to Tracheal Extubation [Срок оценки: From ICU admission until successful extubation (within 48 hours postoperatively)]
Вторичные конечные точки (2)
  • Total Intraoperative Opioid Consumption [Срок оценки: During surgery]
  • Postoperative Opioid Consumption [Срок оценки: 2, 6, 12, 24, and 48 hours after extubation.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Скрининг

Центры проведения

Египет · 1 центр
  • Assiut university hospital — Asyut

Идентификаторы

NCT: NCT07749274 · 04-2026-100513

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗