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
Phase 4
Age: 40Years - 85Years
All Genders
ID04894864
Effect of a Perioperative Opioid Free Anesthesia-Analgesia Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Randomized Study
Led by University of Crete · Updated on 2025-01-07
40
Participants Needed
1
Research Sites
104 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 triggers strong endocrine and metabolic stress responses, leading to inflammation and activation of immune pathways. This trial evaluates whether a multimodal opioid-free anesthesia-analgesia (OFA-A) approach can reduce this surgical stress compared to conventional opioid-based anesthesia-analgesia (OBA-A). The study focuses on measuring inflammatory markers and patient outcomes after elective open AAA repair. Two anesthesia strategies are compared: one using opioids and standard drugs, and the other using a combination of drugs without opioids, including pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol, and magnesium sulfate. Both approaches involve premedication, induction, maintenance, wound infiltration, sedation in intensive care, and postoperative pain control with patient-controlled analgesia pumps. Each regimen aims to manage pain and surgical stress through different drug combinations during and after surgery. Participants aged 40 to 85 undergoing elective open AAA repair will be involved. The study includes detailed monitoring of inflammatory markers such as IL-6, IL-8, IL-10, TNF-a, cortisol, and others at multiple time points before and after surgery. Hemodynamic stability and postoperative pain assessments are also conducted. Researchers will track ICU and hospital stay length to evaluate overall patient outcomes and safety throughout the perioperative period.
CONDITIONS
Brief 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
You may qualify if you...
- Patient consent
- Age between 40 and 85 years old
- Patients undergoing 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 corticosteroid or immunosuppressive drug use
- Intraoperative transfusion with more than 2 units of packed red blood cells
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 hours (duration of surgery and immediate postoperative ICU sedation)
Participants receive either an opioid-based or opioid-free multimodal anesthesia-analgesia strategy during their elective open abdominal aortic aneurysm repair surgery. This includes anesthesia induction, maintenance, and postoperative analgesia during ICU stay and surgical ward care.
1 surgical and ICU stay
Post-operative Follow-up
Duration - 3 days
Participants are monitored for up to 3 days postoperatively for pain assessments, analgesic requirements, and recovery including ICU and hospital discharge length of stay.
Daily visits for 3 days post-surgery
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
Long-term survival after endovascular and open repair of unruptured abdominal aortic aneurysm.
A S Johal, I M Loftus, J R Boyle...
https://pubmed.ncbi.nlm.nih.gov/31747067Concept of the aortic aneurysm repair-related surgical stress: a review of the literature.
Demetrios N Moris, Michalis I Kontos, Eleftherios I Mantonakis...
https://pubmed.ncbi.nlm.nih.gov/25356092Cytokines 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/29770795Endovascular repair of abdominal aortic aneurysm reduces intraoperative cortisol and perioperative morbidity.
Sue Pearson, Tiffany Hassen, J Ian Spark...
https://pubmed.ncbi.nlm.nih.gov/15944585Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm.
Timothy J Wilt, Frank A Lederle, Roderick Macdonald...
https://pubmed.ncbi.nlm.nih.gov/17764213Abdominal aortic aneurysm: a 6-year comparison of endovascular versus transabdominal repair.
W S Moore, V S Kashyap, C L Vescera...
https://pubmed.ncbi.nlm.nih.gov/10493477Comparison 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/11221945Combined 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/23493852Surgically 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