[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659254":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":52,"studyPopulation":44,"armGroups":53,"interventions":66,"overallOfficials":44,"centralContacts":76,"locations":83,"responsibleParty":100,"collaborators":44,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":44,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":86,"whyStopped":44,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Malatya Egitim Ve Arastirma Hastanesi","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Oxidative Stress Index From Preoperative Baseline to 24 Hours After Surgery","Oxidative Stress Index (OSI) will be calculated from serum total oxidant status (TOS) and total antioxidant status (TAS). The primary outcome will be the change in OSI from the preoperative baseline measurement to the measurement obtained 24 hours after surgery. The change in OSI will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.","Preoperative baseline before anesthesia induction and 24 hours after surgery (±2 hours)",[14,17,20,23,26,29,33,37,40],{"measure":15,"description":16,"timeFrame":12},"Change in Total Antioxidant Status (TAS)","Serum total antioxidant status (TAS) will be measured to assess systemic antioxidant capacity. The change in TAS from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":18,"description":19,"timeFrame":12},"Change in Total Oxidant Status (TOS)","Serum total oxidant status (TOS) will be measured to assess systemic oxidant burden. The change in TOS from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":21,"description":22,"timeFrame":12},"Change in Native Thiol Level","Serum native thiol levels will be measured as a component of thiol-disulfide homeostasis. The change in native thiol level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":24,"description":25,"timeFrame":12},"Change in Total Thiol Level","Serum total thiol levels will be measured as a component of thiol-disulfide homeostasis. The change in total thiol level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":27,"description":28,"timeFrame":12},"Change in Disulfide Level","Serum disulfide levels will be calculated as a component of thiol-disulfide homeostasis. The change in disulfide level from preoperative baseline to 24 hours after surgery will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":30,"description":31,"timeFrame":32},"Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)","Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.","During the first 24 hours after surgery",{"measure":34,"description":35,"timeFrame":36},"Total Rescue Opioid Consumption Within 24 Hours After Surgery","Total rescue opioid consumption during the first 24 hours after surgery will be recorded for each participant and compared between the opioid-free anesthesia and opioid-based anesthesia groups.","From the end of surgery to 24 hours after surgery",{"measure":38,"description":39,"timeFrame":36},"Incidence of Postoperative Nausea and Vomiting (PONV)","The occurrence of postoperative nausea and\u002For vomiting (PONV) during the first 24 hours after surgery will be recorded for each participant. The incidence of PONV will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.",{"measure":41,"description":42,"timeFrame":43},"Intraoperative Hemodynamic Parameters","Intraoperative hemodynamic parameters will be assessed using mean arterial pressure (MAP, mmHg) and heart rate (beats per minute), recorded at predefined time points during anesthesia. Changes in these parameters over the intraoperative period will be compared between the opioid-free anesthesia and opioid-based anesthesia groups.","From induction of anesthesia to the end of surgery",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"NON_RANDOMIZED","PARALLEL","Participants will be prospectively enrolled into one of two groups according to the anesthesia strategy selected by the attending anesthesiologist based on routine clinical assessment and patient characteristics. No random allocation will be performed. Both groups will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia. The opioid-free anesthesia group will receive multimodal non-opioid intraoperative analgesia with dexmedetomidine and intravenous lidocaine, while the opioid-based anesthesia group will receive fentanyl-based intraoperative analgesia.","SUPPORTIVE_CARE",{"masking":51,"maskingDescription":44,"whoMasked":44},"NONE","This is a single-center, prospective, randomized, parallel-group clinical study. Adult euthyroid patients scheduled for elective thyroidectomy will be randomized in a 1:1 ratio to opioid-free anesthesia or opioid-based anesthesia. The opioid-based group will receive fentanyl-based intraoperative analgesia. The opioid-free group will receive multimodal non-opioid analgesia with dexmedetomidine and lidocaine. General anesthesia will otherwise be standardized, including propofol-based total intravenous anesthesia, neuromuscular blockade, antiemetic prophylaxis, and postoperative non-opioid analgesia.\n\nThe primary focus of the study is the perioperative oxidative stress response. Venous blood samples will be collected at three time points: before anesthesia induction, 30±10 minutes after extubation in the post-anesthesia care unit, and 24±2 hours after surgery. Serum native thiol, total thiol, disulfide, total antioxidant status, and total oxidant status will be measured, and oxidative stress index will be calculated from total oxidant status and total antioxidant status.\n\nSecondary clinical outcomes will include postoperative pain intensity, rescue opioid consumption, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic stability.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Opioid-Free Anesthesia Group","EXPERIMENTAL","Participants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with multimodal opioid-free intraoperative analgesia. Analgesia will be provided with dexmedetomidine infusion and intravenous lidocaine bolus followed by infusion. No intraoperative opioid will be administered as part of the planned anesthesia protocol.",[59],"Drug: Dexmedetomidine and lidocaine",{"label":61,"type":62,"description":63,"interventionNames":64},"Opioid-Based Anesthesia Group","ACTIVE_COMPARATOR","Participants in this group will undergo elective thyroidectomy under standardized propofol-based total intravenous general anesthesia with fentanyl-based intraoperative analgesia. Fentanyl will be administered at induction and continued as an intravenous infusion during surgery according to the study protocol.",[65],"Drug: Fentanyl (IV)",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":44},"DRUG","Fentanyl (IV)","Fentanyl-based intraoperative analgesia consisting of fentanyl 1-2 mcg\u002Fkg intravenously at induction followed by fentanyl infusion at 1-2 mcg\u002Fkg\u002Fhour during surgery. No additional fentanyl bolus will be administered, and the total intraoperative fentanyl dose will not exceed 5 mcg\u002Fkg.",[61],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":44},"Dexmedetomidine and lidocaine","Dexmedetomidine will be administered intravenously at 0.4-0.7 mcg\u002Fkg\u002Fhour without a loading dose. The infusion will be discontinued 10-15 minutes before the end of surgery. Intravenous lidocaine will be administered as a 1-1.5 mg\u002Fkg bolus followed by a continuous infusion of 1-2 mg\u002Fkg\u002Fhour during surgery. The lidocaine infusion will be discontinued at the end of surgery.",[55],[77],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},"Leman Acun Delen, Associate Professor","CONTACT","+904222118019","2035","leman.delen@ozal.edu.tr",[84],{"facility":85,"status":86,"city":87,"state":44,"zip":88,"country":89,"countryCode":44,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Malatya Turgut Ozal University Faculty of Medicine, Malatya Training and Research Hospital","RECRUITING","Malatya","44000","Turkey (Türkiye)",{"type":91,"coordinates":92},"Point",[93,94],38.31667,38.35018,{"lat":94,"lon":93},[97,98],{"name":78,"role":79,"phone":80,"phoneExt":81,"email":82},{"name":78,"role":99,"phone":44,"phoneExt":44,"email":44},"PRINCIPAL_INVESTIGATOR",{"type":99,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Leman Acun Delen","Associate Professor","100659254","opioid-free-versus-opioid-based-anesthesia-in-thyroid-surgery-100659254",false,"NCT07864155","Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery","Effects of Opioid-Free and Opioid-Based Anesthesia on Perioperative Oxidative Stress Biomarkers in Euthyroid Adult Patients Undergoing Elective Thyroidectomy: A Prospective Clinical Trial","OFA-OBA","Inclusion Criteria:\n\n* Adult patients aged 18 to 65 years\n* Scheduled for elective thyroidectomy\n* American Society of Anesthesiologists physical status I-II\n* Euthyroid status, defined as thyroid-stimulating hormone, free thyroxine, and free triiodothyronine levels within the reference range\n* Able to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Uncontrolled advanced systemic disease, including advanced cardiac, pulmonary, renal, or hepatic failure\n* Active infection\n* Use of high-dose antioxidant supplementation within the last month\n* Widespread inflammation related to malignancy\n* Known severe allergy or contraindication to any study medication\n* Refusal to participate in the study",true,"ALL","18 Years","65 Years",{"count":116,"type":117},110,"ESTIMATED","INTERVENTIONAL",[120],"NA","This study will compare opioid-free anesthesia and opioid-based anesthesia in adult euthyroid patients undergoing elective thyroidectomy. Opioid-based anesthesia is commonly used during surgery, but opioids may be associated with adverse effects such as nausea, vomiting, respiratory depression, hyperalgesia, and increased postoperative opioid use. Opioid-free anesthesia uses non-opioid medications as part of a multimodal strategy to provide intraoperative analgesia.\n\nThe main aim of this prospective randomized study is to evaluate whether opioid-free anesthesia changes the perioperative oxidative stress response compared with opioid-based anesthesia. Oxidative stress will be assessed using serum biomarkers, including native thiol, total thiol, disulfide, total antioxidant status, total oxidant status, and oxidative stress index.\n\nEligible patients will be randomly assigned to receive either opioid-free anesthesia or fentanyl-based opioid anesthesia. Blood samples will be collected before anesthesia induction, 30 minutes after extubation, and 24 hours after surgery. The study will also compare postoperative pain scores, rescue analgesic requirement, postoperative nausea and vomiting, recovery characteristics, and intraoperative hemodynamic variables between the two anesthesia strategies.",[123,124,125],"Thyroidectomy","Oxidative Stress","Anesthesia",[127,128,129,130,131],"Opioid-free anesthesia","Opioid-based anesthesia","Thyroid surgery","Total antioxidant status","Thiol-disulfide homeostasis","2026-10-02",{"date":134,"type":135},"2026-10-07","ACTUAL",{"date":137,"type":135},"2026-04-01",{"date":139,"type":117},"2027-03-31",{"name":5,"class":6},1]