AzTrials
AzTrials

Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative PainEspNCT07749274

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

A study testing Dexmedetomidine, Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB) and Fentanyl in people with Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative Pain, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Dexmedetomidine, Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB) and Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Sep 2026to 1 Nov 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abu Elhasan A Rezk, M.B.B.Ch. contact

+20 1026067713

drabuelhassan.a.rezk@gmail.com

Egypt1 site
  • Assiut university hospital

    Asyut, Ass, 71515

    Abu Elhasan A Rezk, M.B.B.Ch., +20 1026067713, drabuelhassan.a.rezk@gmail.com

Other trials in Egypt

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

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].

Being tested
Dexmedetomidine, Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB), Fentanyl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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.

  • Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB)Procedure or surgery

    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.

  • FentanylDrug

    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.

Study groups in NCT07749274
Study groupRoleWhat they receive
Fast-Track Anesthesia (Dexmedetomidine + ESPB)Experimentalparticipants 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.
Receives: Drug: Dexmedetomidine; Procedure: Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB)
conventional Opioid-Based AnesthesiaActive comparatorParticipants receive conventional general anesthesia using fentanyl-based opioid analgesia according to the institutional standard protocol, together with standardized perioperative and postoperative care.
Receives: Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Tracheal Extubation

    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

    Measured: From ICU admission until successful extubation (within 48 hours postoperatively)

Secondary outcomes (2)
  1. Total Intraoperative Opioid Consumption

    Total opioid administered during surgery, expressed as morphine milligram equivalents (MME).

    Measured: During surgery

  2. Postoperative Opioid Consumption

    Cumulative postoperative opioid requirement, expressed as morphine milligram equivalents (MME).

    Measured: 2, 6, 12, 24, and 48 hours after extubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, single-center, randomized, parallel-group, patient- and outcome-assessor-blinded superiority trial. Eligible patients undergoing elective minimally invasive cardiac surgery will be randomized in a 1:1 ratio to receive either a fast-track anesthesia protocol consisting of dexmedetomidine combined with ultrasound-guided bilateral erector spinae plane block (ESPB) or conventional opioid-based general anesthesia. Apart from the anesthetic intervention, all participants will receive standardized perioperative care, including surgical management, cardiopulmonary bypass protocols, postoperative analgesia, and fast-track extubation criteria. The study will compare the effects of the two anesthetic strategies on extubation time, perioperative opioid consumption, postoperative pain, ICU and hospital length of stay, and perioperative complications. This description is consistent with your study design.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749274
Sponsor's protocol ID
04-2026-100513
Acronym
Esp
Status last verified
Aug 2026
First submitted
1 Aug 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: de-identified individual participant data (IPD) will be made available upon reasonable request for legitimate scientific research purposes, subject to approval by the principal investigator and the Institutional Review Board (IRB). Data sharing will comply with institutional policies and applicable ethical and legal requirements. No information that could directly or indirectly identify study participants will be shared. Access to the data will be granted only after execution of an appropriate data-sharing agreement to ensure the confidentiality and privacy of participants.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in