NCT04894864 Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
| NCT ID | NCT04894864 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Crete |
| Condition | Elective Surgical Procedures |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-10-08 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2020-10-08 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patient Consent 2. Age between 40 and 85 years old 3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair Exclusion Criteria: 1. Immunocompromised patients 2. Patients with active infection 3. Reoperation on the aorta 4. Inflammatory bowel Disease 5. Malignancy 6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis) 7. Chronic corticosteroid or immunosuppressive drug use 8. Intraoperative transfusion with \>2 units of packed Red Blood Cells
Contact & Investigator
Vasileia Nyktari, MD,PhD
STUDY CHAIR
University of Crete, Medical School
Frequently Asked Questions
Who can join the NCT04894864 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Elective Surgical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04894864 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04894864 currently recruiting?
Yes, NCT04894864 is actively recruiting participants. Contact the research team at papastratigakisg@gmail.com for enrollment information.
Where is the NCT04894864 trial being conducted?
This trial is being conducted at Heraklion, Greece.
Who is sponsoring the NCT04894864 clinical trial?
NCT04894864 is sponsored by University of Crete. The principal investigator is Vasileia Nyktari, MD,PhD at University of Crete, Medical School. The trial plans to enroll 40 participants.