Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
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.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2025-11-01
- Completion
- 2026-11-01
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clonidine | Other / unclassified | — | — |
| Comparator | Dexamethasone | Small molecule | 8 mg | — |
| Comparator | Dexamethasone | Small molecule | 16 mg | — |
| Comparator | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | — |
| Comparator | Dexmedetomidine | Other / unclassified | 1 ug/kg | — |
| Comparator | Dexmedetomidine | Other / unclassified | 1.2 ug/kg | — |
| Comparator | Fentanyl | Other / unclassified | 1 ug/kg | — |
| Comparator | Fentanyl | Other / unclassified | 2 ug/kg | — |
| Comparator | Fentanyl | Other / unclassified | 50 ug | — |
| Comparator | Fentanyl | Other / unclassified | 100 ug | — |
| Comparator | Ketamine | Small molecule | 0.3 mg/kg | — |
| Comparator | Ketamine | Small molecule | 0.5 mg/kg | — |
| Comparator | Ketamine | Small molecule | 1 mg/kg | — |
| Comparator | Ketamine | Small molecule | 1.5 mg/kg | — |
| Comparator | Lidocaine | Other / unclassified | 0.5 mg/kg | — |
| Comparator | Lidocaine | Other / unclassified | 1 mg/kg | — |
| Comparator | Morphine | Other / unclassified | 0.1 mg/kg | — |
| Comparator | Morphine | Other / unclassified | 0.12 mg/kg | — |
| Comparator | Opioid-free Anesthesia-Analgesia Strategy | Unknown | 2.5 g | — |
| Comparator | Opioid-free Anesthesia-Analgesia Strategy | Unknown | 5 g | — |
| Comparator | Pregabalin | Small molecule | 25 mg | Oral |
| Comparator | Pregabalin | Small molecule | 50 mg | Oral |
| Comparator | Pregabalin | Small molecule | 150 mg | Oral |
| Comparator | Scopolamine | Unknown | 10 mg | — |
| Comparator | Acetaminophen | Small molecule | 1 g | — |
| Comparator | Cisatracurium | Small molecule | 0.2 mg/kg | — |
| Comparator | Desflurane | Other / unclassified | — | — |
| Comparator | Dexketoprofen Trometamol | Small molecule | 50 mg | — |
| Comparator | Droperidol | Small molecule | 0.625 mg | — |
| Comparator | Ondansetron | Other / unclassified | 4 mg | — |
| Comparator | Opioid-Based Anesthesia-Analgesia Strategy | Unknown | 0.03 mg/kg | Intramuscular |
| Comparator | Opioid-Based Anesthesia-Analgesia Strategy | Unknown | 0.05 mg/kg | Intramuscular |
| Comparator | Opioid-Based Anesthesia-Analgesia Strategy | Unknown | 0.07 mg/kg | Intramuscular |
| Comparator | Propofol | Small molecule | 2 mg/kg | — |
| Comparator | Propofol | Small molecule | 3 mg/kg | — |
| Comparator | Rocuronium | Other / unclassified | 0.6 mg/kg | — |
| Comparator | Rocuronium | Other / unclassified | 1.2 mg/kg | — |
| Comparator | Ropivacaine | Other / unclassified | 75 mg | Other |
| Comparator | Ropivacaine | Other / unclassified | 150 mg | Other |
| Comparator | Tramadol | Other / unclassified | 50 mg | — |
| Comparator | Tramadol | Other / unclassified | 100 mg | — |