[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452533":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":40,"locations":51,"responsibleParty":67,"collaborators":45,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":45,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":45,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":96,"overallStatus":53,"whyStopped":45,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Crete","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-Based Anaesthesia Analgesia","ACTIVE_COMPARATOR","Premedication: IM Midazolam 0.05-0.07mg\u002Fkg. Anesthesia induction: Midazolam 0.03mg\u002Fkg, Propofol 2-3mg\u002Fkg, Fentanyl 1-2mcg\u002Fkg and Cisatracurium 0.2mg\u002Fkg or alternatively Rocuronium 0.6-1.2mg\u002F kg. Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg\u002Fkg, Fentanyl 1-2mcg\u002Fkg during induction and 50-100mcg prn, Paracetamol 1g +\u002F- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g 1x3 +\u002F- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.",[13],"Drug: Opioid-Based Anesthesia-Analgesia Strategy",{"label":15,"type":10,"description":16,"interventionNames":17},"Opioid-Free Anesthesia Analgesia","Premedication: Pregabalin 150mg 1x2, IM Midazolam 0.05-0.07mg\u002Fkg. Anesthesia induction: Midazolam 0.03mg\u002Fkg, Dexmedetomidine 0.5-1mcg\u002Fkg, Lidocaine 1mg\u002Fkg, Propofol 2-3mg\u002Fkg, Ketamine 1-1.5mg\u002Fkg, Hyoscine 10mg, Cisatracurium 0.2mg\u002F kg or alternatively Rocuronium 0.6-1.2mg\u002Fkg, Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg. Anesthesia maintenance: Desflurane set at \\~1 MAC, Dexmedetomidine 0.5-1.2mcg\u002Fkg\u002Fh, Lidocaine 0.5-1mg\u002Fkg\u002Fh, Ketamine 0.3-0.5mg\u002Fkg prn, Paracetamol 1g +\u002F- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg. Wound infiltration: Ropivacaine 75-150mg. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os 1x1 and 25mg 1x1, Paracetamol 1g 1x3 +\u002F- Dexketoprofen trometamol 50mg 1x2. Rescue therapy only: Tramadol 50-100mg.",[18],"Drug: Opioid-free Anesthesia-Analgesia Strategy",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Opioid-Based Anesthesia-Analgesia Strategy","A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:\n\nPremedication: Midazolam, Anaesthesia induction \\& maintenance: Midazolam, Propofol, Fentanyl, Cisatracurium or alternatively Rocuronium, Desflurane, Morphine, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine Surgical ward: Morphine, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol",[9],[26,27],"Opioid-Based Anesthesia","OBA-A",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Opioid-free Anesthesia-Analgesia Strategy","A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:\n\nPremedication: Pregabalin, Midazolam, Anesthesia induction \\& maintenance: Midazolam, Dexmedetomidine, Lidocaine, Propofol, Ketamine, Hyoscine, Cisatracurium or alternatively Rocuronium, Magnesium sulphate, Dexamethasone, Desflurane, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine, Surgical ward: Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam, Pregabalin, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol",[15],[33,34],"Opioid-Free Anesthesia","OFA-A",[36],{"name":37,"affiliation":38,"role":39},"Vasileia Nyktari, MD, PhD","University of Crete, Medical school","STUDY_CHAIR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Periklis Vasilos, MD","CONTACT","00306978702023",null,"p.vassilos@gmail.com",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Georgios Stefanakis, MD, PhD","00306978779726","G_Stefanakis@yahoo.com",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Heraklion","Crete","71110","Greece","GR",{"type":60,"coordinates":61},"Point",[62,63],25.14341,35.32787,{"lat":63,"lon":62},[66],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Periklis Vasilos","Principal Investigator","100452533","phase-4-opioid-free-anaesthesia-analgesia-strategy-on-surgical-stress-and-immunomodulation-in-elective-vats-lobectomy-for-nsclc-100452533",false,"NCT05172739","Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC","Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study","Inclusion Criteria:\n\n* patients undergoing elective VATS lobectomy\n* early stage NSCLC (up to T3N1M0)\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* previous lung surgery\n* preoperative corticosteroid or immunosuppressive drug use\n* uncontrolled Diabetes Mellitus\n* cardiac failure (NYHA 3 and 4)\n* preoperative infection (CRP \\>5mg\u002Fml, WBC \\>10x10\\^9\u002FL)\n* preoperative anemia (Hb\\\u003C12g\u002Fdl)\n* chronic inflammatory diseases\n* inflammatory bowel disease\n\nGroup-specific exclusion criteria:\n\n* OFA-Α: perioperative opioid administration, within the study period\n* OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period","ALL","18 Years","80 Years",{"count":82,"type":83},70,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","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\u002For 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\u002Fanalgesic 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.",[89,90,91,92,93,94,95],"Systemic Inflammatory Response Syndrome","Postoperative Pain, Acute","Postoperative Pain, Chronic","Infections Postoperative","Opioid Use","Anesthesia","Non-small Cell Lung Cancer",[97,98,99,100,101,102,103,104,105],"Opioid-free Anesthesia-Analgesia","Opioid-based Anesthesia-Analgesia","Cytokines","NSCLC","Hemodynamic stability","Immunomodulation","Inflammatory markers","Acute postoperative pain","Chronic postoperative pain","2021-12-10",{"date":108,"type":109},"2021-12-29","ACTUAL",{"date":111,"type":109},"2021-10-01",{"date":113,"type":83},"2026-11-01",{"name":5,"class":6},1]