[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650498":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Pole Sante Oreliance, Polyclinique des Longues Allees","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Titrated Opioid Sparing Anesthesia","EXPERIMENTAL",null,[13],"Procedure: Titrated Opioid Sparing Anesthesia",{"label":15,"type":16,"description":11,"interventionNames":17},"Opioid Free Anesthesia","ACTIVE_COMPARATOR",[18],"Procedure: opioid free anesthesia",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","Opioid-sparing anesthesia using the CARDEAN® index, which enables specific monitoring of nociception during general anesthesia.\n\nBy adjusting sufentanil administration in real time based on variations in surgical painful stimuli, the CARDEAN® index enables titrated opioid-sparing anesthesia (titrated OSA).",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"opioid free anesthesia","anesthesia performed without opioid administration",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Jean-Yves JY Martinez, Doctor","CONTACT","+33 2 38 79 61 85","jyvesmartinez@yahoo.com",[35],{"facility":5,"status":11,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Saran","45770","France","FR",{"type":41,"coordinates":42},"Point",[43,44],1.87601,47.95013,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":32,"phoneExt":11,"email":33},"Jean-Yves Martinez, Doctor",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650498","comparison-between-opioid-sparing-anesthesia-guided-by-the-cardean-index-and-opioid-free-anesthesia-during-total-hip-arthroplasty-100650498",false,"NCT07747142","Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty","Comparaison Entre anesthésie Avec épargne Morphinique guidée Par l'Index CARDEAN® et anesthésie Sans Morphinique au Cours Des Arthroplasties Totales de Hanche : étude randomisée","Inclusion Criteria:\n\n* Men and women\n* Patient aged at least 18 years\n* Signed informed consent\n* American Society of Anesthesiologists (ASA) Class 1 to 3\n* Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure\n* Affiliated with or a beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* ASA Class 4 or 5\n* Emergency hip surgery\n* Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.)\n* Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index)\n* Resting bradycardia \\\u003C 50 bpm\n* Second- or third-degree atrioventricular block\n* Chronic opioid user\n* Refusal of consent\n* Patient unable to read, write, or understand French\n* Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)\n* Adult patient under guardianship, curatorship, or judicial protection\n* Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection\n* Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP","ALL","18 Years",{"count":61,"type":62},140,"ESTIMATED","INTERVENTIONAL",[65],"NA","The proposed study compares two anesthesia techniques; the hypothesis being tested is that titrating sufentanil based on the CARDEAN® index (titrated OSA) does not increase post-operative morphine consumption compared to opioid-free anesthesia (OFA). This CARDEAN®-guided titrated anesthesia approach could potentially allow for hospital discharge as early as 24 hours post-operatively and is compatible with ERAS protocols. The primary objective is to demonstrate that sufentanil administration guided by the CARDEAN® index (titrated OSA) does not increase postoperative morphine consumption compared to opioid-free anesthesia (OFA). This is a prospective, single-center, randomized, single-blind, non-inferiority study.\n\nTwo groups of 70 patients each (140 patients in total) are compared based on the type of intraoperative analgesia: titrated OSA (Arm 1) versus OFA (Arm 2).\n\nRandomization will be performed at a 1:1 ratio and stratified by surgical approach (anterior or lateral approach).",[68],"Total Hip Arthroplasty (THA)",[70,71,72,73],"Cardean","OSA","OFA","anesthesia","NOT_YET_RECRUITING","2026-07-30",{"date":77,"type":78},"2026-08-05","ACTUAL",{"date":80,"type":62},"2026-09-15",{"date":82,"type":62},"2027-10-01",{"name":5,"class":6},1]