Actively Recruiting
Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
Led by University of Crete · Updated on 2021-12-29
70
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological 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, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.
CONDITIONS
Official Title
Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective VATS lobectomy
- Early stage non-small cell lung cancer (up to T3N1M0)
You will not qualify if you...
- Immunocompromised patients
- Previous lung surgery
- Use of corticosteroids or immunosuppressive drugs before surgery
- Uncontrolled diabetes mellitus
- Cardiac failure classified as NYHA 3 or 4
- Preoperative infection (CRP >5mg/ml, WBC >10x10^9/L)
- Preoperative anemia (hemoglobin <12g/dl)
- Chronic inflammatory diseases
- Inflammatory bowel disease
- For opioid-free group: perioperative opioid use during study period
- For opioid-based group: perioperative use of dexmedetomidine, lidocaine infusion, ketamine, gabapentinoids, or corticosteroids during study period
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Crete
Heraklion, Crete, Greece, 71110
Actively Recruiting
Research Team
P
Periklis Vasilos, MD
CONTACT
G
Georgios Stefanakis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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