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

NCT07749274 | Not Yet Recruiting DMC

• 1 other identifier: 04-2026-100513
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Disease Minimally Invasive Cardiac Surgery Postoperative Pain

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (2)

• Total Intraoperative Opioid Consumption

  During surgery

• Postoperative Opioid Consumption

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

Study Arms (2)

Fast-Track Anesthesia (Dexmedetomidine + ESPB)

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Procedure: Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB)

conventional Opioid-Based Anesthesia

ACTIVE COMPARATOR

Participants receive conventional general anesthesia using fentanyl-based opioid analgesia according to the institutional standard protocol, together with standardized perioperative and postoperative care.

Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

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.

Fast-Track Anesthesia (Dexmedetomidine + ESPB)

Ultrasound-Guided Bilateral Erector Spinae Plane Block (ESPB) PROCEDURE

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.

Fast-Track Anesthesia (Dexmedetomidine + ESPB)

Fentanyl DRUG

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.

conventional Opioid-Based Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Ass, 71515, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Central Study Contacts

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

CONTACT

+20 1026067713; drabuelhassan.a.rezk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)