NCT05172739 Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
| NCT ID | NCT05172739 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Crete |
| Condition | Systemic Inflammatory Response Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 70 participants in total. It began in 2021-10-01 with a primary completion date of 2025-11-01.
⚠ 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
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.
Eligibility Criteria
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-Α: perioperative opioid administration, within the study period * OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period
Contact & Investigator
Vasileia Nyktari, MD, PhD
STUDY CHAIR
University of Crete, Medical school
Frequently Asked Questions
Who can join the NCT05172739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Systemic Inflammatory Response Syndrome. 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 NCT05172739 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 NCT05172739 currently recruiting?
Yes, NCT05172739 is actively recruiting participants. Contact the research team at p.vassilos@gmail.com for enrollment information.
Where is the NCT05172739 trial being conducted?
This trial is being conducted at Heraklion, Greece.
Who is sponsoring the NCT05172739 clinical trial?
NCT05172739 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 70 participants.