[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598619":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":68,"centralContacts":74,"locations":84,"responsibleParty":130,"collaborators":102,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":102,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":102,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":158,"overallStatus":87,"whyStopped":102,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Instituto Mexicano del Seguro Social","OTHER_GOV",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine Infusion (LID)","ACTIVE_COMPARATOR","Intra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion.",[13],"Drug: Intravenous Lidocaine infusion + Standard Anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Dexmedetomidine Infusion (DEX)","Intra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure.",[18],"Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia",{"label":20,"type":21,"description":22,"interventionNames":23},"Lidocaine + Dexmedetomidine (LIDEX)","EXPERIMENTAL","Concurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure.",[24],"Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia",{"label":26,"type":27,"description":28,"interventionNames":29},"Saline Placebo","PLACEBO_COMPARATOR","IV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance.",[30],"Drug: 0.9 % Saline Placebo + Standard Anesthesia",[32,40,48,56],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Intravenous Lidocaine infusion + Standard Anesthesia","Continuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion.",[9],[38,39],"Xylocaine®","Lignocaine",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Intravenous Dexmedetomidine infusion + Standard Anesthesia","Continuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion.",[15],[45,46,47],"Precedex®","Dexdor®","DEX",{"type":33,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia","Single syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure.",[20],[53,54,55],"LIDEX","Lidocaine-Dexmedetomidine cocktail","LID + DEX",{"type":33,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"0.9 % Saline Placebo + Standard Anesthesia","Volume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance.",[26],[61,62,63,64,65,66,67],"Normal Saline","Sodium Chloride 0.9 %","Serum Saline","0.9 % NaCl","Isotonic saline","Physiologic saline","Saline solution (IV)",[69,72],{"name":70,"affiliation":5,"role":71},"Dulce María Rascón Martínez, Prof MD, MSc","PRINCIPAL_INVESTIGATOR",{"name":73,"affiliation":5,"role":71},"Arnulfo Calixto Flores, Prof MD, PhD",[75,81],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"Dulce M Rascón Martínez, Prof MD, MSc","CONTACT","+ 52 55 5627 6900","22638","dradulcerascon@gmail.com",{"name":73,"role":77,"phone":78,"phoneExt":82,"email":83},"21607","drrufo@hotmail.com",[85,107],{"facility":86,"status":87,"city":88,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Hospital de Especialidades Centro Medico Nacional Siglo XXI","RECRUITING","Mexico City","06720","Mexico","MX",{"type":93,"coordinates":94},"Point",[95,96],-99.12766,19.42847,{"lat":96,"lon":95},[99,104],{"name":100,"role":77,"phone":101,"phoneExt":102,"email":103},"Dulce María Rascón Martínez, MSc","5542410378",null,"drarascon@hotmail.com",{"name":105,"role":77,"phone":106,"phoneExt":102,"email":83},"Arnulfo Calixto Flores, Researcher","+525534590203",{"facility":108,"status":87,"city":88,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI",{"type":93,"coordinates":110},[95,96],{"lat":96,"lon":95},[113,115,117,120,121,122,124,126,128],{"name":114,"role":77,"phone":78,"phoneExt":79,"email":80},"Dulce M Rascón Martínez, MD, MSc",{"name":116,"role":77,"phone":78,"phoneExt":82,"email":83},"Arnulfo Calixto Flores, MD, PhD",{"name":118,"role":119,"phone":102,"phoneExt":102,"email":102},"Lourdes A Arriaga Pizano, MD, PhD","SUB_INVESTIGATOR",{"name":114,"role":71,"phone":102,"phoneExt":102,"email":102},{"name":116,"role":71,"phone":102,"phoneExt":102,"email":102},{"name":123,"role":119,"phone":102,"phoneExt":102,"email":102},"Eduardo Ferat Osorio, MD, PhD",{"name":125,"role":119,"phone":102,"phoneExt":102,"email":102},"Orlando Carrillo Torres, MD, PhD",{"name":127,"role":119,"phone":102,"phoneExt":102,"email":102},"Aixa D Aguayo Reyes, MD",{"name":129,"role":119,"phone":102,"phoneExt":102,"email":102},"Carlos A Gutiérrez Rojas, MD, Surgeon",{"type":71,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":102,"oldOrganization":102},"Dulce Maria Rascon Martinez","Clinical Research Physician","100598619","phase-4-effect-of-lidocaine-dexmedetomidine-on-pain-inflammation-and-oxidative-stress-after-bariatric-surgery-100598619",false,"NCT07073846","Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.","Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery","Inclusion Criteria:\n\n* Adults aged 18 - 60 years\n* Male or female\n* Elective laparoscopic bariatric surgery\n* Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h\n* ASA physical-status II or III\n\nExclusion Criteria:\n\n* Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks).\n* Current substance abuse or illicit drug use.\n* Previous abdominal surgery within the last 6 months.\n* Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists.\n* Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I\u002FIII anti-arrhythmic drugs.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment).\n* Severe hepatic impairment (Child-Pugh C).\n* Pregnancy or lactation.\n* Chronic opioid consumption \\> 30 mg oral morphine equivalents per day for \\> 4 weeks\n* Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion.\n* Patient cannot communicate\n* Patient does not want to fill in the questionnaire\n* Participation in another interventional study within the past 30 days.\n* Intra-operative conversion to open surgery.\n* Insufficient biological sample for biomarker analysis.\n* Premature discontinuation of the study drug during surgery for any reason that, in the judgement of the treating anaesthesiologist or investigators, prevents adequate exposure or assessment of safety variables (e.g., major haemorrhage \\> 200 mL, anaphylactic shock, failed intubation, inability to extubate, severe metabolic\u002Frespiratory acidosis, transfer to ICU while intubated).","ALL","18 Years","60 Years",{"count":144,"type":145},104,"ESTIMATED","INTERVENTIONAL",[148],"PHASE4","The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity.\n\nThe main questions it aims to answer are:\n\n* Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)?\n* Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced\u002Foxidized glutathione ratio (GSH\u002FGSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo?\n\nResearchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best.\n\nParticipants will:\n\n* Receive an intravenous infusion of their assigned study drug(s) during surgery.\n* Provide three small blood samples (before surgery, immediately after, and three hours after).\n* Complete a short pain questionnaire (IPOQ) 24 hours after surgery.",[151,152,153,154,155,156,157],"Morbid Obesity Requiring Bariatric Surgery","Postoperative Pain","Postoperative Pain Management","Postoperative Analgesia","Postoperative Adjuvant Treatment","Postoperative Inflammatory Markers","Postoperative Inflammatory Response",[159,160,161,162,163,164,165,166,167,168,169],"Bariatric Surgery","Laparoscopic Sleeve Gastrectomy","Laparoscopic Gastric Bypass","Pain Management","Lidocaine-Dexmedetomidine","Multimodal Analgesia","Inflammatory Cytokines","Oxidative Stress","Opioid-sparing Anesthesia","Enhanced Recovery (ERAS)","Postoperarive Oxidative Stress","2025-11-26",{"date":172,"type":173},"2025-11-28","ACTUAL",{"date":175,"type":173},"2025-10-06",{"date":177,"type":145},"2027-07-01",{"name":5,"class":6},2]