[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647888":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":108,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":25,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":25,"enrollmentInfo":124,"targetDuration":25,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":25,"overallStatus":134,"whyStopped":25,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group)","EXPERIMENTAL","The dosage of propofol is adjusted to maintain WLi in the range of 40-70. While the dosage of remifentanil is adjusted to maintain PTi in the range of 40-70. When intraoperative pain stimulation suddenly increases ( PTi \\> 70 ) and lead to increased heart rate and elevated blood pressure, remifentanil 0.5-1 μg \u002F kg will be intravenously injected and observed for 1 min. If PTi still is \\> 70, remifentanil 0.5-1 μg \u002F kg will be added again until PTi reached 40-70.",[13],"Other: Multimodal brain monitoring guided anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group)","ACTIVE_COMPARATOR","The dosage of propofol is adjusted according to the value of BIS, and the BIS is maintained in the range of 40 \\~ 60. The dosage of remifentanil is adjusted according to the experience of anesthesiologists. The intraoperative remifentanil dosage will be maintained between 0.1 μg\u002Fkg\u002Fmin and 0.3μg\u002Fkg\u002Fmin.When it is highly suspected that the sudden increase of pain stimulation during operation leads to the increase of heart rate and blood pressure, remifentanil 0.5 \\~ 1 μg \u002F kg will be given intravenously for 1 min. If the heart rate and blood pressure level don't improve, remifentanil 0.5 \\~ 1 μg \u002F kg is added again until the heart rate and blood pressure have a downward trend and return to the level before the increase.",[19],"Other: Bispectral Index(BIS) monitoring guided anesthesia",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Multimodal brain monitoring guided anesthesia","During the anesthesia induction phase, the dosage administration is guided by the goal of reducing PTi to the range of 40-70, and tracheal intubation is performed when both PTi and WLI are within 40-70. In the anesthesia maintenance phase, the propofol dosage is adjusted according to the WLI value to maintain WLI within 40-70, while the remifentanil dosage is adjusted based on the PTi value to keep PTi within 40-70. In the event of sudden increased intraoperative pain stimulation (PTi \\> 70) accompanied by tachycardia and hypertension, an intravenous bolus of remifentanil at 0.5-1 μg\u002Fkg is administered; after 1 minute of observation, if PTi remains \\> 70, an additional 0.5-1 μg\u002Fkg of remifentanil is given until PTi is brought back to the 40-70 range.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bispectral Index(BIS) monitoring guided anesthesia","During the anesthesia induction phase, the dosage administration is guided by the goal of reducing BIS to the range of 40-60, with remifentanil supplemented based on clinical experience. In the anesthesia maintenance phase, the propofol dosage is adjusted according to BIS values to maintain BIS within 40-60, while the remifentanil dosage is adjusted based on anesthesiologists' experience. When there is a high suspicion of sudden tachycardia and hypertension induced by increased intraoperative pain stimulation, an intravenous bolus of remifentanil at 0.5-1 μg\u002Fkg is administered; after 1 minute of observation, if heart rate and blood pressure show no improvement, an additional 0.5-1 μg\u002Fkg of remifentanil is given until there is a downward trend in heart rate and blood pressure and they return to pre-stimulation levels.",[15],[31],{"name":32,"affiliation":5,"role":33},"Tianlong Wang, Doctor","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","0086139 1052 5304","w_tl5595@hotmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Wei Xiao, Doctor","008613810971299","kitten15@126.com",[44,64,76,92],{"facility":45,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Xuanwu Hospital Capital Medical University","Beijing","Beijing Municipality","10053","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,59,61],{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},"Tianlong Wang",{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Wei Xiao","SUB_INVESTIGATOR",{"facility":65,"status":25,"city":46,"state":47,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Peking University International Hospital",{"type":52,"coordinates":67},[54,55],{"lat":55,"lon":54},[70,74],{"name":71,"role":36,"phone":72,"phoneExt":25,"email":73},"Lan Yao, Doctor","008613671010819","yaolan@pkuih.edu.cn",{"name":75,"role":33,"phone":25,"phoneExt":25,"email":25},"Lan Yao",{"facility":77,"status":25,"city":78,"state":79,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan",{"type":52,"coordinates":81},[82,83],113.64861,34.75778,{"lat":83,"lon":82},[86,90],{"name":87,"role":36,"phone":88,"phoneExt":25,"email":89},"Jianjun Yang, Doctor","008613357739238","jianjunyang1971@163.com",{"name":91,"role":33,"phone":25,"phoneExt":25,"email":25},"Jianjun Yang",{"facility":93,"status":25,"city":94,"state":95,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology","Wuhan","Hubei",{"type":52,"coordinates":97},[98,99],114.26667,30.58333,{"lat":99,"lon":98},[102,106],{"name":103,"role":36,"phone":104,"phoneExt":25,"email":105},"Ailin Luo, Doctor","008613507122565","alluo@tjh.tjmu.edu.cn",{"name":107,"role":33,"phone":25,"phoneExt":25,"email":25},"Ailin Luo",{"type":109,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[111,113,114],{"name":112,"class":6},"Tongji Hospital",{"name":65,"class":6},{"name":77,"class":6},"100647888","the-impact-of-multimodal-brain-monitoring-on-postoperative-outcomes-in-elderly-patients-undergoing-major-abdominal-surgery-100647888",false,"NCT07713355","The Impact of Multimodal Brain Monitoring on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery","Impact of Multimodal Brain Monitoring Under General Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery: A Multicenter, Prospective, Single-blind, Randomized Controlled Study","Inclusion Criteria:\n\nAged ≥65 years, regardless of gender; Scheduled for elective abdominal surgery with general anesthesia duration (from anesthesia induction to surgery completion) ≥ 2 hours; American Society of Anesthesiologists (ASA) physical status classification of I-III; Body mass index (BMI) of 18.5-29.9 kg\u002Fm²; Postoperative hospital stay expected to exceed 72 hours; Compliant with ethical standards, with voluntary signed informed consent.\n\nExclusion Criteria:\n\nSevere cardiovascular diseases, including:\n\nHistory of myocardial infarction within the past 6 months; Bradycardia (resting heart rate \\\u003C50 beats\u002Fmin); Uncontrolled hypertension (sitting systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg during screening); Sitting systolic blood pressure ≤90 mmHg during screening; History of severe valvular heart disease; Uncontrolled severe respiratory infections: e.g., severe pneumonia, acute bronchitis.\n\nAbnormal liver function: Aspartate Aminotransferase (AST) and\u002For Alanine Aminotransferase (ALT) ≥2.5×Upper Limit of Normal (ULN), Total Bilirubin (TBIL) ≥1.5×Upper Limit of Normal (ULN); Abnormal renal function: urea or blood urea nitrogen (BUN) ≥1.5×Upper Limit of Normal (ULN), serum creatinine \\>Upper Limit of Normal (ULN); Admission hemoglobin A1c (HbA1c) ≥6.5% or ≥2 fasting blood glucose measurements ≥180 mg\u002Fdl (10 mmol\u002FL) and\u002For random blood glucose ≥200 mg\u002FdL (≈11.1 mmol\u002FL); Preoperative anemia (Hemoglobin \\[Hb\\] ≤90 g\u002FL), thrombocytopenia (Platelet \\[PLT\\] ≤80×10⁹\u002FL), hypoproteinemia (Albumin \\[Alb\\] ≤30 g\u002FL); History of drug abuse and\u002For alcoholism within the past 2 years (alcoholism defined as daily average alcohol consumption \\>2 units, where 1 unit = 360 mL beer or 45 mL 40% ethanol liquor or 150 mL wine); Neurological diseases (e.g., stroke within 6 months, Alzheimer's disease, Parkinson's disease, mental disease, myasthenia gravis) or psychiatric disorders (e.g., schizophrenia, mania, bipolar disorder, delirium), history of long-term use of neuropsychiatric medications, or cognitive impairment; Allergy or contraindication to study medications; Patients refusing or unable to cooperate with the study; Scheduled for pancreatic surgery; Other conditions deemed inappropriate for participation by the investigator.","ALL","65 Years",{"count":125,"type":126},368,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this clinical trial is to investigate the effect of multimodal brain monitoring under general anesthesia on postoperative outcomes in elderly patients undergoing abdominal surgery.The research hypothesis is that multimodal brain monitoring under general anesthesia can reduce the incidence of postoperative composite complications and improve postoperative outcomes in elderly patients undergoing major abdominal surgery.\n\nEligible patients will be randomly assigned in a 1:1 ratio to the Multimodal Brain Monitoring under General Anesthesia Group (MBMGA group) and the Bispectral Index Monitoring under General Anesthesia Group (BIS group). The primary outcome is the postoperative composite complication rate . Secondary outcomes include intraoperative hyperglycemia, adverse events during anesthesia induction and maintanance, changes in blood pressure and heart rate, intraoperative hypotension, the dosage of perioperative anesthetics and vasoactive drugs, changes in serum cortisol, cardiac troponin I, blood creatinine (Cr) level, extubation time and awake time, the rate of transferring to ICU or AICU, The time to first use analgesia pump and the cumulative dose of postoperative oxycodone, systemic complications, hospitalization time, first exhaust time , first oral intake time, rate of second surgery and mortality within 30 days postoperatively.\n\nParticipants will:\n\n1. Undergo routine preoperative fasting for 6-8 hours;\n2. Prior to anesthesia induction, cooperate with the establishment of intravenous access, arterial catheterization, monitoring of physiological parameters, blood sample collection, and receive fluid preloading;\n3. During surgery, for patients in the MBMGA group , propofol and remifentanyl will be adjusted according to multimodal brain monitoring indices (WLi and PTi), while for patients in the BIS group, only propofol will be adjusted based on bispectral index and remifentanyl will be adjusted according to anesthesiologists' experience; simultaneously, vital signs, including respiration, body temperature, fluid therapy, blood pressure, and heart rate regulation, will be monitored and managed.\n4. After surgery, endotracheal tubes will be removed once extubation criteria are met, and patients will be transferred to the PACU, where they will receive routine monitoring and will be discharged from the PACU upon meeting corresponding scoring criteria;\n5. Participates in follow-ups on the day of surgery and for 1-30 days postoperatively, during which investigators will record the primary outcome and secondary outcomes.",[132,133],"Anesthesia, General","Major Abdominal Surgeries","NOT_YET_RECRUITING","2026-07-15",{"date":137,"type":138},"2026-07-20","ACTUAL",{"date":140,"type":126},"2026-08-01",{"date":142,"type":126},"2028-12-30",{"name":5,"class":6},4]