[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431190":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":40,"locations":51,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":45,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":45,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":99,"overallStatus":53,"whyStopped":45,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Crete","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-Based Anesthesia 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\u002Fkg. 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. ICU stay sedation: Remifentanil infusion, until removal of the endotracheal tube. Surgical ward: PCA pump with Morphine for the first 3 postoperative days. Additional postoperative analgesia: Paracetamol 1g x3 +\u002F- Dexketoprofen trometamol 50mg x2. 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 50-150mg x2, IM Midazolam 0.05-0.07mg\u002Fkg. Anesthesia induction: Midazolam 0.03mg\u002Fkg, Dexdmedetomidine 0.5-1mcg\u002Fkg, Lidocaine 1mg\u002Fkg, Propofol 2-3mg\u002Fkg, Ketamine 1-1.5mg\u002Fkg, Hyoscine 10mg, Cisatracurium 0.2mg\u002Fkg 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 0.2-1.2mcg\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. ICU sedation: Dexmedetomidine + Lidocaine infusions, until removal of the ETT. Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine and Midazolam for the first 3 postoperative days. Additionally, Pregabalin 50mg per os x1 and 25mg x1, up to x2, Paracetamol 1g x3 +\u002F- Dexketoprofen trometamol 50mg x2. 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 as described in the Opioid-Based arm of the study.",[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-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.",[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},"George Papastratigakis, MD","CONTACT","00306979056672",null,"papastratigakisg@gmail.com",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Georgios Stefanakis, MD","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":42,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Principal Investigator",[71],{"name":72,"class":6},"University Hospital of Crete","100431190","phase-4-opioid-free-anesthesia-analgesia-strategy-and-surgical-stress-in-elective-open-abdominal-aortic-aneurysm-repair-100431190",false,"NCT04894864","Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair","Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study","Inclusion Criteria:\n\n1. Patient Consent\n2. Age between 40 and 85 years old\n3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair\n\nExclusion Criteria:\n\n1. Immunocompromised patients\n2. Patients with active infection\n3. Reoperation on the aorta\n4. Inflammatory bowel Disease\n5. Malignancy\n6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)\n7. Chronic corticosteroid or immunosuppressive drug use\n8. Intraoperative transfusion with \\>2 units of packed Red Blood Cells","ALL","40 Years","85 Years",{"count":84,"type":85},40,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity\u002Fmortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international \"opioid-crisis\" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic\u002Fanalgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects.\n\nOur basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.",[91,92,93,94,95,96,97,98],"Elective Surgical Procedures","Postoperative Pain","Anesthesia","Opioid Use","Abdominal Aortic Aneurysm Without Rupture","Vascular Surgical Procedure","Interleukin 6","Immunomodulators",[100,101,102,103,104,105,106],"Opioid-free Anesthesia-Analgesia","Cytokines","Opioid-based Anesthesia-Analgesia","Haemodynamic Stability","Open Abdominal Aortic Aneurysm Repair","Immunomodulation","Inflammatory Markers","2026-06-13",{"date":109,"type":110},"2026-06-16","ACTUAL",{"date":112,"type":110},"2020-10-08",{"date":114,"type":85},"2027-09-01",{"name":5,"class":6},1]