[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497096":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":29,"responsibleParty":51,"collaborators":55,"id":58,"slug":24,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":24,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":31,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"G.Gennimatas General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid Based Anaesthesia","ACTIVE_COMPARATOR","This arm will receive:\n\n* 2 mcg\u002Fkg fentanyl in 10 ml volume\n* 0.2 mL\u002Fkg\u002Fh remifentanil infusion\n* 0.1 mg\u002Fkg morphine",[13],"Drug: Opioid based anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Opioid Free Anaesthesia","This arm will receive\n\n* 40 mg\u002Fkg magnesium sulfate in 100 ml N\u002FS infusion\n* 0.4 mcg\u002Fkg dexmedetomidine, max total dose 50mcg in 50 ml N\u002FS infusion\n* 0.3 mg\u002Fkg ketamine in 10 ml volume\n* 0.2 ml\u002Fkg of the Multimix regimen in 100 ml N\u002FS infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine).\n* 0.2 ml\u002Fkg\u002Fh of the Multimix regimen in 100 ml N\u002FS infusion as a continuous infusion",[18],"Drug: Opioid Free Anaesthesia",[20,25],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","* 40 mg\u002Fkg magnesium sulfate in 100 ml N\u002FS infusion\n* 0.4 mcg\u002Fkg dexmedetomidine, max total dose 50mcg in 50 ml N\u002FS infusion\n* 0.3 mg\u002Fkg ketamine in 10 ml volume\n* 0.2 ml\u002Fkg of the Multimix regimen in 100 ml N\u002FS infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine).\n* 0.2 ml\u002Fkg\u002Fh of the Multimix regimen in 100 ml N\u002FS infusion as a continuous infusion. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg\u002Fkg) based on a nociceptive level value \\> 25 or elevation of Heart Rate and\u002For Blood Pressure \\>20%.\n\nPlacebo infusions of normal saline will be prepared to enable blinding.",[15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Opioid based anesthesia","* 2 mcg\u002Fkg fentanyl in 10 ml volume\n* 0.2 mL\u002Fkg\u002Fh remifentanil infusion\n* 0.1 mg\u002Fkg morphine. Except for standard analgesic strategies, both groups will receive fentanyl as a rescue dose (1mcg\u002Fkg) based on a nociceptive level value \\> 25 or elevation of Heart Rate and\u002For Blood Pressure \\>20%.\n\nPlacebo infusions of normal saline will be prepared to enable blinding.",[9],[30],{"facility":5,"status":31,"city":32,"state":24,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Athens","11527","Greece","GR",{"type":37,"coordinates":38},"Point",[39,40],23.72784,37.98376,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":24,"email":47},"Panagiotis Chatzistavridis, MD, MSc","CONTACT","+306972871556","p_chatzistavridis@yahoo.gr",{"name":49,"role":45,"phone":24,"phoneExt":24,"email":50},"Kassiani Theodoraki, Dr","ktheod@med.uoa.gr",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Panagiotis Chatzistavridis","Principal Investigator",[56],{"name":57,"class":6},"Aristotle University Of Thessaloniki","100497096",false,"NCT05752799","Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids","Inclusion Criteria:\n\n* Age \\>18y and \\\u003C75y\n* morbid obesity confirmed diagnosis\n* American Society of Anesthesiologists (ASA) II-III\n* elective laparoscopic sleeve gastrectomy surgery\n* signed informed consent\n\nExclusion Criteria:\n\n* bradycardia, bundle branch block, hypotension, postural hypotension\n* obstructive sleep apnoea\n* history of depression\n* chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent\n* refusal to participate","ALL","18 Years","75 Years",{"count":67,"type":68},70,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:\n\n* Will the total dose of intraoperative opioid be reduced?\n* Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia.\n\nThe Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion.\n\nRescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.",[74,75],"Opioid Use, Unspecified","Bariatric Surgery Candidate",[77,78,79,80,81],"morbid obesity","opioid free anaesthesia","nociception level","analgesia","bariatric surgery","2026-04-25",{"date":84,"type":85},"2026-04-28","ACTUAL",{"date":87,"type":85},"2023-01-01",{"date":89,"type":68},"2027-06-01",{"name":5,"class":6},1]