Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
NCT04894864

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

Led by University of Crete ยท 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 surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

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

CONTACT

G

Georgios Stefanakis, MD

CONTACT

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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