Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
ID04894864

Study of Opioid-Free Versus Opioid-Based Anesthesia-Analgesia in Elective Open Abdominal Aortic Aneurysm Repair and Their Effects on Surgical Stress Response

Led by University of Crete · Updated on 2025-01-07

40

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

Sponsors

U

University of Crete

Lead Sponsor

U

University Hospital of Crete

Collaborating Sponsor

AI-Summary

What this Trial Is About

Open abdominal aortic aneurysm (AAA) repair is a high-risk surgery that causes intense stress responses in the body, including activation of inflammatory processes and immune system changes. This trial evaluates how a new opioid-free anesthesia and analgesia strategy compares to the traditional opioid-based approach in reducing the surgical stress response during elective open AAA repair. The study is a Phase 4 prospective randomized trial that aims to improve patient outcomes by managing the body's reaction to surgery more effectively. The study compares two anesthesia approaches: a multimodal opioid-free anesthesia-analgesia (OFA-A) strategy using drugs like pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol, and magnesium sulfate, and a conventional opioid-based anesthesia-analgesia (OBA-A) strategy. Both strategies are applied perioperatively during elective open abdominal aortic infrarenal aneurysm repair. The trial investigates whether the OFA-A approach can reduce inflammatory and stress responses compared to the standard opioid-based method. Participants undergo surgery with their assigned anesthesia technique while researchers monitor inflammatory markers such as IL-6, IL-8, IL-10, TNF-a, CRP, cortisol, AVP, and white blood cell count before and after surgery at multiple time points. Hemodynamic stability and fluid requirements are also closely tracked during and after surgery. The study measures these outcomes up to 24 hours postoperatively to assess the surgical stress response and potential benefits of the opioid-free anesthesia method.

CONDITIONS

Official Title

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient consent to participate
  • Age between 40 and 85 years old
  • Scheduled for elective open abdominal aortic infrarenal aneurysm repair
Not Eligible

You will not qualify if you...

  • Immunocompromised patients
  • Patients with active infection
  • Reoperation on the aorta
  • Inflammatory bowel disease
  • Malignancy
  • Chronic inflammatory conditions such as rheumatoid arthritis or psoriatic arthritis
  • Chronic use of corticosteroids or immunosuppressive drugs
  • Intraoperative transfusion with more than 2 units of packed red blood cells

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Crete

Heraklion, Crete, Greece, 71110

Actively Recruiting

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Research Team

G

George Papastratigakis, MD

G

Georgios Stefanakis, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Cytokines as biomarkers of inflammatory response after open versus endovascular repair of abdominal aortic aneurysms: a systematic review.

Diamantis I Tsilimigras, Fragiska Sigala, Georgios Karaolanis...

https://pubmed.ncbi.nlm.nih.gov/29770795

Comparison of open transabdominal AAA repair with endovascular AAA repair in reduction of postoperative stress response.

K Salartash, W C Sternbergh, J W York...

https://pubmed.ncbi.nlm.nih.gov/11221945

Combined general-epidural anesthesia with continuous postoperative epidural analgesia preserves sigmoid colon perfusion in elective infrarenal aortic aneurysm repair.

Venetiana Panaretou, Ioanna Siafaka, Dimitrios Theodorou...

https://pubmed.ncbi.nlm.nih.gov/23493852

Surgically positioned paravertebral catheters and postoperative analgesia after open abdominal aortic aneurysm repair.

Samuel Jessula, Logan Atkinson, Patrick Casey...

https://pubmed.ncbi.nlm.nih.gov/31153699