RecruitingPhase 4Other

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

Sponsored by University of Crete

NCT ID
NCT05172739
Target Enrollment
70 participants
Start Date
2021-10-01
Est. Completion
2026-11-01

About This Study

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 Studied

Systemic Inflammatory Response SyndromePostoperative Pain, AcutePostoperative Pain, ChronicInfections PostoperativeOpioid UseAnesthesiaNon-small Cell Lung Cancer

Interventions

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

Eligibility

Age:18 Years - 80 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

University of Crete
Heraklion, Crete, Greece

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Periklis Vasilos, MD
CONTACT
00306978702023p.vassilos@gmail.com
Georgios Stefanakis, MD, PhD
CONTACT
00306978779726G_Stefanakis@yahoo.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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