[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553011":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":24,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":35,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Ziekenhuis Oost-Limburg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","The comparator is a placebo, namely pure saline (NaCl 0.9%), which will be administered following the same regimen as the intervention.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexmedetomidine","ACTIVE_COMPARATOR","Nocturnal administration of dexmedetomidine (0.2-1.0 mcg\u002Fkg\u002Fh) during the first night after surgery. Dexmedetomidine infusion, not preceded by a bolus administration, will be started at 0.4 mcg\u002Fkg\u002Fh in the intervention group at 8 p.m. the day of surgery. Dexmedetomidine infusion will be titrated every 30 minutes with 0.1 mcg\u002Fkg\u002Fh steps until a RASS of -1 to -3 (drowsy, light to moderate sedation) is reached. The infusion will be discontinued at 6 a.m. the next morning.",[19],"Drug: Dexmedetomidine",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Steven Thiessen","CONTACT","3289325294","steven.thiessen@zol.be",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Genk","Limburg","3600","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],5.50082,50.965,{"lat":45,"lon":44},[48,49],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},{"name":29,"role":50,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100553011","phase-4-the-effect-of-nocturnal-dexmedetomidine-on-postoperative-sleep-quality-and-fatigue-after-major-surgery-in-elderly-patients-dexsleep-study-100553011",false,"NCT06480539","The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study","DEXSLEEP","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for thoracoscopic lung surgery.\n\nExclusion Criteria:\n\n* lack of informed consent or inability to give informed consent;\n* ≥ 2nd-degree atrioventricular block without pacemaker;\n* uncontrolled hypotension (blood pressure \\< 90\u002F60 mmHg);\n* known hypersensitivity to dexmedetomidine or to any of the excipients;\n* acute cerebrovascular conditions;\n* urgent, not elective surgery.","ALL","60 Years",{"count":63,"type":64},102,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function.\n\nDexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients. However, whether the administration of dexmedetomidine translates into reduced postoperative fatigue and\u002For weakness and improved enhanced recovery after surgery by improving sleep, is currently unknown.\n\nThe DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine, as compared to placebo (i.e. no dexmedetomidine), on postoperative quality of recovery, postoperative fatigue and muscle weakness.",[70,71,72],"Postoperative Fatigue","Postoperative Sleep Disturbances","Surgical Stress Response",[74,75,76,77,78,79,80,15],"Major surgery","Enhanced Recovery After Surgery (ERAS)","Elderly patients","Quality of recovery","Postoperative fatigue","Postoperative muscle weakness","Postoperative sleep disturbances","2026-04-07",{"date":83,"type":84},"2026-04-08","ACTUAL",{"date":86,"type":84},"2024-06-06",{"date":88,"type":64},"2026-04",{"name":5,"class":6},1]