Long-term relative survival following surgery for abdominal aortic aneurysm: a review.
P E Norman, J B Semmens, M M Lawrence-Brown
https://pubmed.ncbi.nlm.nih.gov/11336844Actively Recruiting
Led by University of Crete · Updated on 2025-01-07
40
Participants Needed
1
Research Sites
365 weeks
Total Duration
U
University of Crete
Lead Sponsor
U
University Hospital of Crete
Collaborating Sponsor
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
Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
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Total: 1 location
1
University of Crete
Heraklion, Crete, Greece, 71110
Actively Recruiting
G
George Papastratigakis, MD
G
Georgios Stefanakis, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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