[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507872":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":11,"studyPopulation":11,"armGroups":66,"interventions":77,"overallOfficials":87,"centralContacts":92,"locations":102,"responsibleParty":349,"collaborators":351,"id":355,"slug":356,"hasResults":357,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":357,"sex":363,"minAge":364,"maxAge":11,"enrollmentInfo":365,"targetDuration":11,"studyType":368,"phases":369,"briefSummary":371,"conditions":372,"keywords":11,"overallStatus":105,"whyStopped":11,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":11},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"death",null,"Day 30",{"measure":14,"description":15,"timeFrame":12},"Postoperative acute kidney injury (PO-AKI)","The PO-AKI will be defined as an increase to 1.5 times the reference level, or as more than 0.3 mg.dl-1 (i.e. 26.5 µmol.l-1) between the last preoperative value and the maximal value observed after surgery, or urine volume \\\u003C 0.5 ml.kg-1.h-1 for 6 hours, according to the recommendations of the Acute Kidney Injury Network",{"measure":17,"description":18,"timeFrame":12},"cardiovascular complication","postoperative myocardial infarction, acute heart failure, acute\u002Fnon pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation",{"measure":20,"description":21,"timeFrame":12},"neurological complication","Stroke or transient ischemic attack",{"measure":23,"description":24,"timeFrame":12},"Post-operative delirium (POD)","Post-operative delirium (POD) will be evaluated using the 3-minute Diagnostic Confusion Assessment Method (3D-CAM), appropriated and validated for the assessment of delirium in the postoperative period, or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for the intubated patients.",[26,29,31,34,37,40,42,46,48,50,52,54,56,58],{"measure":27,"description":11,"timeFrame":28},"doses of hypnotics administered","during surgery",{"measure":30,"description":11,"timeFrame":28},"doses opioids administered;",{"measure":32,"description":33,"timeFrame":28},"number and duration of hypotensive periods","an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.",{"measure":35,"description":36,"timeFrame":28},"time spent within the desired range of sedation:","Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0 or SedLine® Sedation Monitor : Patient State Index (PSI) between 25 and 50 AND Suppression Ratio (SR) at 0 or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0 The anesthetist will have access to the value of sedation monitoring in the \"intervention\" group; these data will be recorded but not available to the anesthetist in the \"control\" group: they will be analyzed at the end of the study to answer this point.",{"measure":38,"description":39,"timeFrame":28},"time spent within the desired range of analgesia:","Nociception monitor PMD-200® : Nociception Level (NOL) between 10 and 25. The anesthetist will have access to the value of sedation and analgesia monitoring in the \"intervention\" group; these data will be recorded but not available to the anesthetist in the \"control\" group: they will be analyzed at the end of the study to answer this point.",{"measure":41,"description":11,"timeFrame":28},"doses of vasopressive amines (ephedrine or norepinephrine) administered;",{"measure":43,"description":44,"timeFrame":45},"pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)","VAS 0 to 10 \\[0 corresponds to no pain - 10 corresponds to maximum pain\\]","At 48 Hours after surgery",{"measure":47,"description":11,"timeFrame":45},"dose of opioid administered;",{"measure":49,"description":11,"timeFrame":45},"incidence of awareness and recall during anesthesia (explicit memory).",{"measure":51,"description":11,"timeFrame":12},"acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)",{"measure":53,"description":11,"timeFrame":12},"duration of stay in Intensive Care Unit (ICU);",{"measure":55,"description":11,"timeFrame":12},"rate of unexpected ICU admission, or readmission",{"measure":57,"description":11,"timeFrame":12},"duration of hospital stay;",{"measure":59,"description":11,"timeFrame":12},"early hospital readmission rate",{"allocation":61,"interventionModel":62,"interventionModelDescription":11,"primaryPurpose":63,"observationalModel":11,"timePerspective":11,"maskingInfo":64},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":65,"maskingDescription":11,"whoMasked":11},"NONE",[67,72],{"label":68,"type":69,"description":11,"interventionNames":70},"Intervention Group","EXPERIMENTAL",[71],"Procedure: anesthesia guided by sedation and analgesia monitoring",{"label":73,"type":74,"description":11,"interventionNames":75},"Control Group","PLACEBO_COMPARATOR",[76],"Procedure: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":11},"PROCEDURE","anesthesia guided by sedation and analgesia monitoring","Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by\n\n* Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0;\n* or SedLine® Sedation Monitor : Patient State Index (PSi) between 25 and 50;\n* or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0;\n\nand the level of nociception by :\n\n* Nociception monitor PMD-200® : Nociception Level (NoL) between 10 and 25.",[68],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":11},"anesthesia performed according only to the clinical judgment of the anesthetist as usual practice","Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring",[73],[88],{"name":89,"affiliation":90,"role":91},"David CHARIER, MD, PhD","CHU DE SAINT-ETIENNE","PRINCIPAL_INVESTIGATOR",[93,97],{"name":89,"role":94,"phone":95,"phoneExt":11,"email":96},"CONTACT","+33.4.77.82.85.65","david.charier@chu-st-etienne.fr",{"name":98,"role":94,"phone":99,"phoneExt":100,"email":101},"Marlène BONNEFOI, CRA","(0)477828822","+33","marlene.bonnefoi@chu-st-etienne.fr",[103,119,128,141,153,165,177,189,201,213,225,237,252,264,276,288,300,313,325,337],{"facility":104,"status":105,"city":106,"state":11,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Chu D'Amiens Picardie","RECRUITING","Amiens","80054","France","FR",{"type":111,"coordinates":112},"Point",[113,114],2.3,49.9,{"lat":114,"lon":113},[117],{"name":118,"role":91,"phone":11,"phoneExt":11,"email":11},"Hervé DUPONT, MD PhD",{"facility":120,"status":105,"city":106,"state":11,"zip":121,"country":108,"countryCode":109,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Clinique Victor Pauchet","80090",{"type":111,"coordinates":123},[113,114],{"lat":114,"lon":113},[126],{"name":127,"role":91,"phone":11,"phoneExt":11,"email":11},"Pierre HUETTE, MD",{"facility":129,"status":130,"city":131,"state":11,"zip":132,"country":108,"countryCode":109,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Chru de Besancon","NOT_YET_RECRUITING","Besançon","25030",{"type":111,"coordinates":134},[135,136],6.01815,47.24878,{"lat":136,"lon":135},[139],{"name":140,"role":91,"phone":11,"phoneExt":11,"email":11},"Guillaume BESCH, MD PhD",{"facility":142,"status":105,"city":143,"state":11,"zip":144,"country":108,"countryCode":109,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Polyclinique Bordeaux Nord Aquitaine","Bordeaux","33300",{"type":111,"coordinates":146},[147,148],-0.58046,44.84124,{"lat":148,"lon":147},[151],{"name":152,"role":91,"phone":11,"phoneExt":11,"email":11},"Philippe RICHEBE, MD, PhD",{"facility":154,"status":130,"city":155,"state":11,"zip":156,"country":108,"countryCode":109,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Hôpital de La Cavale Blanche","Brest","29200",{"type":111,"coordinates":158},[159,160],-4.48628,48.39029,{"lat":160,"lon":159},[163],{"name":164,"role":91,"phone":11,"phoneExt":11,"email":11},"Anaïs CAILLARD, PhD",{"facility":166,"status":130,"city":167,"state":11,"zip":168,"country":108,"countryCode":109,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Chu Clermont-Ferrand","Clermont-Ferrand","63000",{"type":111,"coordinates":170},[171,172],3.08682,45.77969,{"lat":172,"lon":171},[175],{"name":176,"role":91,"phone":11,"phoneExt":11,"email":11},"Bertille PAQUETTE, MD",{"facility":178,"status":130,"city":179,"state":11,"zip":180,"country":108,"countryCode":109,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Chu de Grenoble","Grenoble","38700",{"type":111,"coordinates":182},[183,184],5.71479,45.17869,{"lat":184,"lon":183},[187],{"name":188,"role":91,"phone":11,"phoneExt":11,"email":11},"Pierre BOUZAT, MD PhD",{"facility":190,"status":105,"city":191,"state":11,"zip":192,"country":108,"countryCode":109,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Chu de Lille","Lille","59037",{"type":111,"coordinates":194},[195,196],3.05512,50.63391,{"lat":196,"lon":195},[199],{"name":200,"role":91,"phone":11,"phoneExt":11,"email":11},"Gilles LEBUFFE, MD PhD",{"facility":202,"status":130,"city":203,"state":11,"zip":204,"country":108,"countryCode":109,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"APHM - Centre Hôpital Marseille Nord","Marseille","13015",{"type":111,"coordinates":206},[207,208],5.38107,43.29695,{"lat":208,"lon":207},[211],{"name":212,"role":91,"phone":11,"phoneExt":11,"email":11},"Marc LEONE, MD PhD",{"facility":214,"status":130,"city":215,"state":11,"zip":216,"country":108,"countryCode":109,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Chu de Nantes","Nantes","44093",{"type":111,"coordinates":218},[219,220],-1.55336,47.21725,{"lat":220,"lon":219},[223],{"name":224,"role":91,"phone":11,"phoneExt":11,"email":11},"Raphaël CINOTTI, MD PhD",{"facility":226,"status":130,"city":227,"state":11,"zip":228,"country":108,"countryCode":109,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Hôpital l'Archet","Nice","06200",{"type":111,"coordinates":230},[231,232],7.26608,43.70313,{"lat":232,"lon":231},[235],{"name":236,"role":91,"phone":11,"phoneExt":11,"email":11},"Romain ROZIER, MD",{"facility":238,"status":105,"city":239,"state":11,"zip":240,"country":108,"countryCode":109,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Chu de Nimes","Nîmes","30000",{"type":111,"coordinates":242},[243,244],4.35788,43.83665,{"lat":244,"lon":243},[247,250],{"name":248,"role":249,"phone":11,"phoneExt":11,"email":11},"Yann GRICOURT, MD","SUB_INVESTIGATOR",{"name":251,"role":91,"phone":11,"phoneExt":11,"email":11},"Philippe CUVILLON, MD PhD",{"facility":253,"status":105,"city":254,"state":11,"zip":255,"country":108,"countryCode":109,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Hopital Bichat Claude Bernard","Paris","75018",{"type":111,"coordinates":257},[258,259],2.3488,48.85341,{"lat":259,"lon":258},[262],{"name":263,"role":91,"phone":11,"phoneExt":11,"email":11},"Aurélie GOUEL, MD",{"facility":265,"status":105,"city":266,"state":11,"zip":267,"country":108,"countryCode":109,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Chu Lyon Sud","Pierre-Bénite","69495",{"type":111,"coordinates":269},[270,271],4.82424,45.70359,{"lat":271,"lon":270},[274],{"name":275,"role":91,"phone":11,"phoneExt":11,"email":11},"Arnaud FRIGGERI, MD, PhD",{"facility":277,"status":105,"city":278,"state":11,"zip":279,"country":108,"countryCode":109,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Chu de Poitiers","Poitiers","86000",{"type":111,"coordinates":281},[282,283],0.34348,46.58261,{"lat":283,"lon":282},[286],{"name":287,"role":91,"phone":11,"phoneExt":11,"email":11},"Matthieu BOISSON, MD",{"facility":289,"status":130,"city":290,"state":11,"zip":291,"country":108,"countryCode":109,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Hôpital Saint Charles","Saint-Dié","88100",{"type":111,"coordinates":293},[294,295],6.94921,48.28429,{"lat":295,"lon":294},[298],{"name":299,"role":91,"phone":11,"phoneExt":11,"email":11},"Claude MEISTELMAN, MD, PhD",{"facility":301,"status":105,"city":302,"state":11,"zip":303,"country":108,"countryCode":109,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Chu St-Etienne","Saint-Etienne","42100",{"type":111,"coordinates":305},[306,307],4.39,45.43389,{"lat":307,"lon":306},[310,312],{"name":311,"role":249,"phone":11,"phoneExt":11,"email":11},"Serge MOLLIEX, MD, PhD",{"name":89,"role":91,"phone":11,"phoneExt":11,"email":11},{"facility":314,"status":105,"city":315,"state":11,"zip":316,"country":108,"countryCode":109,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Chu de Toulouse","Toulouse","31059",{"type":111,"coordinates":318},[319,320],1.44367,43.60426,{"lat":320,"lon":319},[323],{"name":324,"role":91,"phone":11,"phoneExt":11,"email":11},"Fabrice FERRE, MD PhD",{"facility":326,"status":130,"city":327,"state":11,"zip":328,"country":108,"countryCode":109,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Institut Gustave Roussy","Villejuif","94800",{"type":111,"coordinates":330},[331,332],2.35992,48.7939,{"lat":332,"lon":331},[335],{"name":336,"role":91,"phone":11,"phoneExt":11,"email":11},"Cyrus MOTAMED, MD",{"facility":338,"status":105,"city":339,"state":11,"zip":340,"country":108,"countryCode":109,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Médipole Lyon Villeurbanne","Villeurbanne","69100",{"type":111,"coordinates":342},[343,344],4.8795,45.76601,{"lat":344,"lon":343},[347],{"name":348,"role":91,"phone":11,"phoneExt":11,"email":11},"Vincent COLLANGE, MD",{"type":350,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[352],{"name":353,"class":354},"Direction Générale de l'Offre de Soins","OTHER_GOV","100507872","prevention-of-organ-dysfunction-and-mortality-by-monitoring-the-administration-of-opioids-and-hypnotics-in-patients-at-high-postoperative-risk-100507872",false,"NCT05893030","Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk","Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.","OPTI-TWO","Inclusion Criteria:\n\n* patients affiliated to the French Social Security;\n* informed and signed consent to participating in the study;\n* planned postoperative hospitalization \\> 48 hours;\n* patients over 75 years of age with at least one of the following postoperative risk factors:\n\n  * ischemic coronary disease;\n  * history of compensated or prior heart failure;\n  * stroke;\n  * significant arrhythmias: fibrillation or auricular flutter with ventricular response \\> 100\u002Fminute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);\n  * peripheral vascular disease;\n  * chronic obstructive pulmonary disease;\n  * chronic respiratory failure;\n  * renal insufficiency, defined by a creatinine \\> 175 µmol.l-1 (2 mg.dl-1);\n  * insulin therapy for diabetes;\n  * active cancer;\n  * chronic alcohol abuse;\n  * dementia.\n* elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device\n\nNon inclusion criteria:\n\n* Patients who meet one or more of the preoperative following criteria will not be included:\n* acute heart failure or acute myocardial infarction;\n* complete arrhythmia due to atrial fibrillation;\n* acute respiratory failure or pneumonia;\n* septic shock;\n* acute stroke;\n* cardiac surgery;\n* open chest surgery;\n* opioid free anesthesia;\n* intraoperative ketamine at a dose \\> 0.25 mg.kg-1; \\> 0.25 mg\u002Fkg or or intravenous electric syringe\n* lidocaine or dexmedetomidine by continuous infusion;\n* refusal to participate in the study;\n* patient under guardianship, conservatorship, or unable to understand the study.","ALL","75 Years",{"count":366,"type":367},1132,"ESTIMATED","INTERVENTIONAL",[370],"NA","Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.\n\nThe study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.",[373],"Sedation and Analgesia Monitoring","2026-10-06",{"date":376,"type":377},"2026-10-08","ACTUAL",{"date":379,"type":377},"2023-10-12",{"date":381,"type":367},"2028-02",{"name":5,"class":6},20]