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Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC

RecruitingPhase 4Ages 18 Years - 80 YearsAllUniversity of Crete
NCT05172739 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 mech

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * patients undergoing elective VATS lobectomy * early stage NSCLC (up to T3N1M0) Exclusion Criteria: * Immunocompromised patients * previous lung surgery * preoperative corticosteroid or immunosuppressive drug use * uncontrolled Diabetes Mellitus * cardiac failure (NYHA 3 and 4) * preoperative infection (CRP \>5mg/ml, WBC \>10x10\^9/L) * preoperative anemia (Hb\<12g/dl) * chronic inflammatory diseases * inflammatory bowel disease Group-specific exclusion criteria: * OFA-ฮ‘: perioperative opioid administration, within the study period * OBA-ฮ‘: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period
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What it tests

  • Opioid-Based Anesthesia-Analgesia Strategy
  • Opioid-free Anesthesia-Analgesia Strategy
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Where

1 site
University of Crete
Heraklion, Greece
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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