Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT05172739

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

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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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective VATS lobectomy
  • Early stage non-small cell lung cancer (up to T3N1M0)
Not Eligible

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

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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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