[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599458":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":109,"centralContacts":113,"locations":122,"responsibleParty":139,"collaborators":44,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":44,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":44,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":170,"overallStatus":190,"whyStopped":44,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"University Hospital Dubrava","OTHER",[8,18,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid based anesthesia (OBA)","ACTIVE_COMPARATOR","Premedication: pantoprazole 40 mg i.v. 1h before surgery. Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg\u002Fkg ideal body weight), and rocuronium (0.8 to 1 mg\u002Fkg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room. To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). For pain levels of 4 or higher on a numerical rating scale (NRS), treatment options include metamizole (2.5 g), pethidine (25 to 100 mg), or tramadol (100 mg). For nausea and vomiting, intravenous doses of ondansetron or metoclopramide are provided as needed.",[13,14,15,16,17],"Drug: Sufentanil","Procedure: Opioid based Anesthesia","Drug: Metoclopramide 10mg","Drug: Ondasetron 4mg","Drug: Dexamethasone, 8 mg intravenously",{"label":19,"type":10,"description":20,"interventionNames":21},"Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine","Premedication: pregabalin 75 mg peroraly et pantoprazole 40mg i.v. A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml\u002Fhour. After this initial period, anesthetic induction is conducted using propofol at a dose of 1-2 mg\u002Fkg IBW and rocuronium at 0.8-1 mg\u002Fkg IBW. Anesthesia is sustained with sevoflurane maintained at 0.5-1 MAC, adjusted per BIS readings. The anesthetic mixture was maintained at a rate of 5-10 ml per hour adjusted according to the patient's blood pressure and pulse. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). To prevent nausea and vomiting, patients receive intraoperative dexamethasone 8 mg and thiethylperazine 6.5 mg intravenously.",[22,23,24,25,26,17],"Drug: Dexmedetomidin","Drug: ketamine","Drug: Lidocain","Procedure: Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine","Drug: Thiethylperazine",{"label":28,"type":29,"description":30,"interventionNames":31},"Opioid free anesthesia based on thoracic paravertebral block (TPVB)","EXPERIMENTAL","Premedication: pantoprazol 40mg i.v. Preoperative TPVB is executed at the Th5, Th7, and Th9 levels bilaterally. The skin at each level are infiltrated with 1.5 ml of 1% lidocaine. Subsequently, 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level and flushed with 1 ml of 5% glucose. In the operating room a induction is carried out with propofol administered at a dosage of 2-2.5 mg\u002Fkg of ideal body weight (IBW) and rocuronium at 0.8-1 mg\u002Fkg of IBW. Anesthesia is maintained with an infusion of propofol at 100 mcg\u002Fkg of total body weight (TBW) per minute, with adjustments made to achieve a targeted BIS value between 40-60. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). Prophylaxis of PONV is dexamethasone 8 mg previously administered within the thoracic paravertebral block, with intraoperative administration of 10 mg metoclopramide.\n\nCompletely opioid-free interventions.",[32,33,34,35,36,37,15],"Drug: Levobupivacaine","Drug: Dexamethasone contained in the solution for thoracic paravertebral block","Drug: Adrenaline","Procedure: Opioid free anesthesia based on thoracic paravertebral block","Device: Ultrasound guided thoracic paravertebral block","Device: Nerve stimulator for peripheral nerve blocks",[39,45,48,51,55,58,61,65,72,76,82,89,93,97,101,105],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Levobupivacaine","Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).",[28],null,{"type":40,"name":46,"description":42,"armGroupLabels":47,"otherNames":44},"Dexamethasone contained in the solution for thoracic paravertebral block",[28],{"type":40,"name":49,"description":42,"armGroupLabels":50,"otherNames":44},"Adrenaline",[28],{"type":40,"name":52,"description":53,"armGroupLabels":54,"otherNames":44},"Dexmedetomidin","A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml\u002Fhour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.",[19],{"type":40,"name":56,"description":53,"armGroupLabels":57,"otherNames":44},"ketamine",[19],{"type":40,"name":59,"description":53,"armGroupLabels":60,"otherNames":44},"Lidocain",[19],{"type":40,"name":62,"description":63,"armGroupLabels":64,"otherNames":44},"Sufentanil","Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg\u002Fkg ideal body weight), and rocuronium (0.8 to 1 mg\u002Fkg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room.",[9],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"PROCEDURE","Opioid free anesthesia based on thoracic paravertebral block","Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized without the use of opioids, with general anesthesia and pain blockade using a thoracic paravertebral block",[28],[71],"OFA based on TPVB",{"type":66,"name":73,"description":74,"armGroupLabels":75,"otherNames":44},"Opioid based Anesthesia","Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized with opioids and general anesthesia",[9],{"type":66,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine","Patients who are scheduled for laparoscopic gastrectomy will be anesthetized without the use of opioids and under general anesthesia, with analgesia by intravenous administration of dexmedetomidine, ketamine and lidocaine.",[19],[81],"OFA",{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"DEVICE","Ultrasound guided thoracic paravertebral block","Patients are positioned prone, with the identification of the 1st rib achieved using a convex XX Hz ultrasound probe. The left and right transverse processes of the 5th, 7th, and 9th thoracic vertebrae are marked accordingly. TPVB is executed in a paramedian sagittal oblique scan utilizing an in-plane needle insertion approach at the Th5, Th7, and Th9 levels bilaterally. An insulated echogenic needle, sized between 10-15 cm and 22-20 G, is employed. The skin and subcutaneous tissue at each level are infiltrated with 1.5 ml of 1% lidocaine.\n\nUltrasound guidance combined with nerve stimulation (dual monitoring) is utilized at each corresponding paravertebral space. Verification of the paravertebral space is established through visualization of pleural displacement, as observed via the ultrasound probe following the injection of 1 ml of 5% glucose, as well as via a motor response at a current intensity of 0.3-0.5 mA.",[28],[88],"Ultrasound guided TPVB",{"type":83,"name":90,"description":91,"armGroupLabels":92,"otherNames":44},"Nerve stimulator for peripheral nerve blocks","During the application of the thoracic paravertebral block, verification of the distance of the insulated echogenic needle tip from the thoracic spinal nerve is monitored using via a motor response at a current intensity of 0.3-0.5 mA.",[28],{"type":40,"name":94,"description":95,"armGroupLabels":96,"otherNames":44},"Metoclopramide 10mg","To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and metoclopramide (10 mg) intraoperatively",[9,28],{"type":40,"name":98,"description":99,"armGroupLabels":100,"otherNames":44},"Ondasetron 4mg","To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intraoperatively.",[9],{"type":40,"name":102,"description":103,"armGroupLabels":104,"otherNames":44},"Thiethylperazine","To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and thiethylperazine (6.5 mg) intravenously.",[19],{"type":40,"name":106,"description":107,"armGroupLabels":108,"otherNames":44},"Dexamethasone, 8 mg intravenously","To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously.",[9,19],[110],{"name":111,"affiliation":5,"role":112},"IVO JURISIC, MD","STUDY_CHAIR",[114,118],{"name":111,"role":115,"phone":116,"phoneExt":44,"email":117},"CONTACT","+385989050015","i.jurisic.kbd@gmail.com",{"name":119,"role":115,"phone":120,"phoneExt":44,"email":121},"VESNA JURISIC, MD","38598508833","v.jurisic03@gmail.com",[123],{"facility":5,"status":44,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"Zagreb","City of Zagreb","10000","Croatia","HR",{"type":130,"coordinates":131},"Point",[132,133],15.97798,45.81444,{"lat":133,"lon":132},[136,137],{"name":111,"role":115,"phone":116,"phoneExt":44,"email":117},{"name":111,"role":138,"phone":44,"phoneExt":44,"email":44},"PRINCIPAL_INVESTIGATOR",{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","IVO JURISIC","MD","100599458","non-opioid-anesthesia-based-on-thoracic-paravertebral-block-during-laparoscopic-sleeve-gastrectomy-100599458",false,"NCT07084753","Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy","Comparison of Opioid-based Anesthesia, Opioid-free Anesthesia Based on Intravenous Drugs and Opioid-free Anesthesia With Thoracic Paravertebral Block, in Patients Undergoing Laparoscopic Gastric Bypass Surgery for Obesity","Inclusion Criteria:\n\n-. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)\n\n* body mass index of 30 kg\u002Fm² or greater\n* patients classified as ASA status 2-3.\n\nExclusion Criteria:\n\n* allergies to the intended medications\n* patient refusal\n* uncontrolled psychiatric disorders\n* intracranial pathology\n* cerebrovascular damage\n* any factors impairing effective communication\n\nAdditional Exclusion Criteria:\n\n1. For patients receiving thoracic paravertebral block (TPVB):\n\n   \\- the presence of infection at the puncture site\n2. For the OFA group:\n\n   * 2nd or 3rd-degree atrioventricular block\n   * bradycardia with a heart rate below 50 beats per minute\n   * coronary artery disease,\n   * cardiomyopathy.","ALL","18 Years","70 Years",{"count":154,"type":155},36,"ESTIMATED","INTERVENTIONAL",[158],"NA","Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. A thoracic paravertebral block is performed by inserting a needle into the intercostal spaces on the back, approximately 4 cm lateral to the spine. Many studies support excellent pain control with this technique, during and after surgery in thoracic and abdominal surgery. Investigators aim to achieve faster patient mobility after surgery, rapid recovery of bowel function, reduced nausea and vomiting, and maximum pain control. The use of opioids, which can additionally cause respiratory suppression and drowsiness, is avoided.\n\nAt any time in case of need to switch from laparoscopic to open surgery, equally adequate anesthesia and postoperative analgesia are ensured without the need to change the approach to the same. In this study, the basic scientific assumption (hypothesis) of the researchers is that non-opioid anesthesia with thoracic paravertebral block provides adequate pain control during and long-term after the surgical procedure, without the side effects of opioid anesthesia.\n\nThe main goal of the study is to determine which type of anesthesia results in the best pain control and most significantly reduces complications of anesthesia and surgery in overweight patients who are scheduled for laparoscopic longitudinal gastrectomy and partial\u002Ftotal gastrectomy.",[161,162,163,164,165,166,167,168,169],"Obese Patients","Bariatric Surgical Pain","Bariatric Surgery (Sleeve Gastrectomy )","Non-Opioid Pain Management","PONV","Postoperative Analgesia","Postoperative Pain","Thoracic Paravertebral Block","Opioid Free Anesthesia",[171,172,173,174,175,176,177,178,179,180,181,182,183,184,81,185,164,165,186,187,188,189],"thoracic paravertebral block","obese patients","bariatric surgery","sleeve gastrectomy","postoperative pain management","anesthesia recovery period","non-opioid anesthesia","recovery after bariatric surgery","TPVB","OFA based on thoracic paravertebral block","Visceral pain, Postoperative","Opioid based anesthesia","Opioid free anesthesia","OBA","Recovery Period, Anesthesia","Postoperative analgesia","Postoperative pain","Bariatric Surgery, Pain","Opioid free anesthesia, dexmedetomidine, ketamine, lidocaine","NOT_YET_RECRUITING","2025-07-17",{"date":193,"type":194},"2025-07-24","ACTUAL",{"date":196,"type":155},"2025-07-30",{"date":198,"type":155},"2025-10",{"name":141,"class":6},1]