Actively Recruiting
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
Eligibility Criteria
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
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
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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