[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582309":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":107,"collaborators":18,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":18,"enrollmentInfo":119,"targetDuration":18,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":18,"overallStatus":129,"whyStopped":18,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group NOL","EXPERIMENTAL","Morphinomimetics will be administered according to NOL Index values.",[13],"Procedure: Nol index",{"label":15,"type":16,"description":17,"interventionNames":18},"Group control","NO_INTERVENTION","Morphinomimetics will be administered according to the usual criteria.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Nol index","Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Fabien ESPITALIER, PU-PH","CONTACT","+33 2 47 47 17 47","fabien.espitalier@univ-tours.fr",[32,48,61,74,87,100],{"facility":33,"status":18,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Chu Angers","Angers","France","FR",{"type":38,"coordinates":39},"Point",[40,41],-0.55202,47.47156,{"lat":41,"lon":40},[44],{"name":45,"role":28,"phone":46,"phoneExt":18,"email":47},"Sigismond LASOCKI, PH","+33 6 03 16 62 95","SiLasocki@chu-angers.fr",{"facility":49,"status":18,"city":50,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"CH BLOIS","Blois",{"type":38,"coordinates":52},[53,54],1.32912,47.59432,{"lat":54,"lon":53},[57],{"name":58,"role":28,"phone":59,"phoneExt":18,"email":60},"Thibault CAMOZZI, PH","+33 2 54 55 66 37","thibaultcamozzi@hotmail.com",{"facility":62,"status":18,"city":63,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Chu Brest","Brest",{"type":38,"coordinates":65},[66,67],-4.48628,48.39029,{"lat":67,"lon":66},[70],{"name":71,"role":28,"phone":72,"phoneExt":18,"email":73},"Anaïs CAILLARD, PH","+33 2 98 22 33 33","anais.caillard@chu-brest.fr",{"facility":75,"status":18,"city":76,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Chu Nantes","Nantes",{"type":38,"coordinates":78},[79,80],-1.55336,47.21725,{"lat":80,"lon":79},[83],{"name":84,"role":28,"phone":85,"phoneExt":18,"email":86},"Raphaël CINOTTI, PU-PH","+33 2 40 08 47 31","Raphael.CINOTTI@chu-nantes.fr",{"facility":88,"status":18,"city":89,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Chru Tours Sar1","Tours",{"type":38,"coordinates":91},[92,93],0.70398,47.39484,{"lat":93,"lon":92},[96],{"name":97,"role":28,"phone":98,"phoneExt":18,"email":99},"Marc LAFFON, PU-PH","+33 2 47 47 38 10","marc.laffon@univ-tours.fr",{"facility":101,"status":18,"city":89,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Chru Tours Sar2",{"type":38,"coordinates":103},[92,93],{"lat":93,"lon":92},[106],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":108,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100582309","optimization-of-morphinomimetic-administration-intraoperatively-evaluation-of-the-impact-of-the-nol-index-on-the-occurrence-of-postoperative-adverse-events-related-to-morphinomimetics-100582309",false,"NCT06861634","Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics","Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics: A Randomized Controlled Trial","NOL-Impact","Inclusion Criteria:\n\n* Male or female\n* Subject aged ≥ 18 years\n* Affiliated with a social security scheme\n* Having given written informed consent to participate study\n* Admitted for major surgery expected to last more than 2 hours\n* Under general anesthesia with tracheal intubation\n* For a planned hospital stay of at least 48 hours\n* Participant's ability to understand the nature and objectives of the study to comply with study requirements.\n\nExclusion Criteria:\n\n* Contraindication to one of the drugs used for anesthesia\n* Urgent surgery\n* Intracranial surgery\n* Transplant surgery\n* Cardiac surgery\n* Surgery with scheduled local anesthesia\n* Patient requiring postoperative intubation\n* Neuromuscular disease\n* Patient chronically using morphinomimetics\n* Chronic pain patient\n* Patients with a history of sleep apnea\n* Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)\n* Patients wearing false nails and\u002For nail polish\n* Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion\u002Fdefibrillation);\n* Patient with an implanted pacemaker or defibrillator\n* Treatment with β-blockers\n* Preoperative cardiac arrhythmia\n* Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women\n* Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty\n* Participation in other interventional research involving an experimental drug or medical device.","ALL","18 Years",{"count":120,"type":121},332,"ESTIMATED","INTERVENTIONAL",[124],"NA","Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects.\n\nHowever, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics.\n\nThe Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?",[127,128],"Anesthesia","Intensive Care Medicine","NOT_YET_RECRUITING","2025-03-05",{"date":132,"type":133},"2025-03-06","ACTUAL",{"date":135,"type":121},"2025-03",{"date":137,"type":121},"2028-04",{"name":5,"class":6},6]