[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654031":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":71,"studyPopulation":62,"armGroups":72,"interventions":85,"overallOfficials":94,"centralContacts":101,"locations":108,"responsibleParty":128,"collaborators":62,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":62,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":62,"enrollmentInfo":141,"targetDuration":62,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":154,"whyStopped":62,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Subjective sleep quality on Post-Operative Day 1 (POD1)","Subjective sleep quality on Post-Operative Day 1 (POD1), measured by the Richards-Campbell Sleep Questionnaire (RCSQ) total score. The RCSQ total score is the mean value of the first 5 items, ranging from 0 to 100. Higher scores indicate better subjective sleep quality.","Morning of Post-Operative Day 1 (POD1)",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Sleep efficiency (SE%)","Sleep efficiency (SE%) derived from wrist-worn actigraphy.","First Post-Operative Night",{"measure":19,"description":20,"timeFrame":17},"Total sleep time (TST, minutes)","Total sleep time (TST, minutes) derived from wrist-worn actigraphy.",{"measure":22,"description":23,"timeFrame":17},"Wake After Sleep Onset (WASO, minutes)","Wake After Sleep Onset (WASO, minutes) derived from wrist-worn actigraphy.",{"measure":25,"description":26,"timeFrame":17},"Sleep Latency (SL, minutes)","Sleep Latency (SL, minutes) derived from wrist-worn actigraphy.",[28,32,36,40,43,47,51,55],{"measure":29,"description":30,"timeFrame":31},"Incidence and severity of postoperative delirium","Incidence and severity of postoperative delirium assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM). This tool yields a binary diagnosis of delirium (present or absent), as well as grading for delirium severity.","Twice daily (Morning 08:00-10:00 and Evening 18:00-20:00), covering Post-Operative Day 1 (POD1), Post-Operative Day 2 (POD2), Post-Operative Day 3 (POD3)",{"measure":33,"description":34,"timeFrame":35},"Total intraoperative consumption of anesthetic agents","Cumulative intraoperative consumption of propofol and remifentanil.","Intraoperative period",{"measure":37,"description":38,"timeFrame":39},"Post-operative Quality of Recovery-15 (QoR-15) score","Post-operative recovery quality assessed by the Post-operative Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150. Higher scores indicate better postoperative recovery quality.","Morning of Post-Operative Day 3 (POD3)",{"measure":41,"description":42,"timeFrame":41},"Incidence of peri-operative adverse events","From study drug administration to hospital discharge, up to POD7 Description: Postoperative nausea and vomiting (PONV); respiratory depression (SpO2 \\\u003C90% lasting \\>2 min); delayed emergence (Steward recovery score \\\u003C4 lasting \\>30 min post-extubation); bradycardia (HR \\\u003C50 bpm); hypothermia (core temp \\\u003C35.5℃); electrolyte disorders (hypokalemia, hyponatremia); and Serious Adverse Events (SAEs).",{"measure":44,"description":45,"timeFrame":46},"Intra-operative core body temperature","Intra-operative core body temperature measured during surgery.","From completion of endotracheal intubation until the end of surgical procedure",{"measure":48,"description":49,"timeFrame":50},"Incidence and severity of post-anesthetic shivering","Incidence and severity grading of post-anesthetic shivering.","From the end of surgical procedure until prior to ward transfer",{"measure":52,"description":53,"timeFrame":54},"Fasting blood glucose","Peripheral fasting blood glucose concentration.","Baseline (morning on the day of surgery), morning of Post-Operative Day 1 (POD1))",{"measure":56,"description":57,"timeFrame":58},"Blood lactate","Peripheral blood lactate concentration.","Baseline (morning on the day surgery, fasting state), morning of Post-Operative Day 1 (POD1)",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":62,"timePerspective":62,"maskingInfo":64},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":65,"maskingDescription":62,"whoMasked":66},"QUADRUPLE",[67,68,69,70],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Postoperative sleep disturbance is common after thoracoscopic surgery, which may aggravate pain response and impair postoperative recovery. Sodium oxybate is a sedative-hypnotic agent. This trial intends to explore whether intraoperative administration of sodium oxybate can improve postoperative sleep quality in surgical patients, and to evaluate its peri-operative safety.",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"Sodium oxybate group","EXPERIMENTAL","Intravenous sodium oxybate administered during general anesthesia",[78],"Drug: sodium oxybate",{"label":80,"type":81,"description":82,"interventionNames":83},"Placebo group","PLACEBO_COMPARATOR","Intravenous placebo administered during general anesthesia",[84],"Drug: Placebo",[86,91],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":62},"DRUG","sodium oxybate","Intravenous administration during general anesthesia",[74],{"type":87,"name":92,"description":89,"armGroupLabels":93,"otherNames":62},"Placebo",[80],[95,98],{"name":96,"affiliation":5,"role":97},"Jiangbei Cao, MD","PRINCIPAL_INVESTIGATOR",{"name":99,"affiliation":5,"role":100},"Weixing Zhao, MD","STUDY_DIRECTOR",[102,106],{"name":96,"role":103,"phone":104,"phoneExt":62,"email":105},"CONTACT","+86-10-01066937485","cjb2000@sina.com",{"name":99,"role":103,"phone":104,"phoneExt":62,"email":107},"1325859408@qq.com",[109],{"facility":5,"status":62,"city":110,"state":62,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Beijing","100853","China","CN",{"type":115,"coordinates":116},"Point",[117,118],116.39723,39.9075,{"lat":118,"lon":117},[121,122,123,125,126],{"name":96,"role":103,"phone":104,"phoneExt":62,"email":105},{"name":99,"role":103,"phone":104,"phoneExt":62,"email":107},{"name":96,"role":124,"phone":62,"phoneExt":62,"email":62},"SUB_INVESTIGATOR",{"name":99,"role":124,"phone":62,"phoneExt":62,"email":62},{"name":127,"role":124,"phone":62,"phoneExt":62,"email":62},"Mingyu Zhang",{"type":129,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"SPONSOR_INVESTIGATOR","Jingsheng Lou","Professor, Department of Anesthesiology","100654031","sodium-oxybate-for-postoperative-sleep-disturbance-after-thoracic-surgery-100654031",false,"NCT07794982","Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery","Effect of Single Intraoperative Infusion of Sodium Oxybate on Postoperactive Sleep Disturbance in Patients Undergoing Elective Thoracoscopic Lobectomy or Segmentectomy: A Single-center,Randomized,Double-blind,Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Patients scheduled for elective VATS lobectomy or segmentectomy under general anesthesia, who provide written informed consent, with anticipated surgical duration \\> 1 hour.\n* Age ≥ 65 years old.\n* American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ.\n* Baseline cognitive function: Mini-Mental State Examination (MMSE) score ≥ 17, adjusted for educational level.\n\nExclusion Criteria:\n\n* History of chronic alcohol abuse or illicit substance use.\n* Surgical completion time at or after 20:00.\n* History of central nervous system diseases (epilepsy, Parkinson's disease, dementia, prior stroke) or prior neurosurgical procedures.\n* Post-operative unplanned intensive care unit (ICU) admission.\n* Regular pre-operative use of sodium oxybate, benzodiazepines or other potent central nervous system depressants, unless discontinued for at least 5 elimination half-lives before surgery.","ALL","65 Years",{"count":142,"type":143},360,"ESTIMATED","INTERVENTIONAL",[146],"NA","This is a single-center, randomized, double-blind, placebo-controlled trial. Three hundred-sixty adult patients undergoing elective thoracoscopic surgery will be randomly allocated at a 1:1 ratio to receive either intraoperative sodium oxybate or placebo. The primary objective is to compare postoperative sleep quality between the two groups. Secondary outcomes include postoperative pain scores, incidence of adverse events and other peri-operative indicators.",[149],"Thoracic Surgical Procedures",[88,151,152,153],"postoperative sleep quality","thoracoscopic surgery","peri-operative anesthesia","NOT_YET_RECRUITING","2026-08-26",{"date":157,"type":158},"2026-08-31","ACTUAL",{"date":160,"type":143},"2026-08",{"date":162,"type":143},"2027-12",{"name":130,"class":6},1]