[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602451":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":42,"responsibleParty":69,"collaborators":73,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":102,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Beijing Tsinghua Chang Gung Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: RL-Guided Hemodynamic Management","EXPERIMENTAL","Participants in this arm will have their intraoperative hemodynamic management guided by the RL-PRAIS clinical decision support system. The system provides real-time dosing recommendations for vasoactive agents (norepinephrine, phenylephrine, and ephedrine) based on continuous invasive arterial blood pressure monitoring and patient state features. Recommendations are displayed on a bedside screen at 1-minute decision epochs. The attending anesthesiologist retains full clinical autonomy and is responsible for all final dosing decisions. Anesthetic management (propofol, remifentanil, sevoflurane\u002Fdesflurane) follows institutional standard protocols in both arms.",[13],"Device: Device: AI Clinical Decision Support System",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Standard Anesthesia Care","ACTIVE_COMPARATOR","Participants in this arm will receive standard-of-care general anesthesia management. The anesthesiologist will make all clinical decisions based on their professional judgment and standard institutional practices, without the aid of the investigational AI system.",[19],"Procedure: Procedure: Standard of Care Anesthesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Device: AI Clinical Decision Support System","An AI-based software system that provides real-time, on-screen recommendations to the anesthesiologist regarding drug administration and adjustments to maintain optimal patient physiological parameter",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Procedure: Standard of Care Anesthesia","Standard anesthesia management according to institutional guidelines. The attending anesthesiologist makes all clinical decisions based on their expertise and judgment without input from the investigational AI system.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Gao Zhifeng, MD","CONTACT","15801249466","btchgzf@hotmail.com",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Zheng Zhang, MD","18801238359","18756235568@163.com",[43,61],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University People's Hospital","Beijing","Beijing Municipality","100044","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":59,"phoneExt":26,"email":60},"Yi Feng, MD","+8618975802249","1810301235@pku.edu.cn",{"facility":62,"status":26,"city":45,"state":46,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Beijing Tsinghua Changgung Hospital","102218",{"type":51,"coordinates":65},[53,54],{"lat":54,"lon":53},[68],{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zhifeng Gao","Professor, Department of Anesthesiology",[74],{"name":44,"class":6},"100602451","ai-assisted-blood-pressure-control-during-anesthesia-100602451",false,"NCT07123675","AI-Assisted Blood Pressure Control During Anesthesia","A Dual-Center, Randomized, Controlled, Proof-of-Concept Trial to Evaluate an AI-Based Decision Support System for Intraoperative Blood Pressure Management","RL-PRAIS PoC","Inclusion Criteria:\n\n* Age 18 to 85 years\n* Scheduled for elective non-cardiac surgery\n* Receiving intravenous-inhalation combined general anesthesia with tracheal intubation\n* ASA physical status I to IV\n* Anesthesia maintenance plan includes propofol for continuous sedation, remifentanil for continuous analgesia, and sevoflurane or desflurane for inhalation anesthesia\n* Continuous invasive arterial blood pressure monitoring during surgery\n* Continuous monitoring of heart rate and Bispectral Index (BIS) during surgery\n* Expected surgical duration of at least 2 hours\n\nExclusion Criteria:\n\n* Emergency surgery\n* Continuous infusion of remifentanil or propofol for less than 30 minutes during surgery\n* Receiving continuous intravenous sedatives other than propofol during the maintenance phase\n* Receiving continuous intravenous analgesics other than remifentanil during the maintenance phase\n* Inhaled anesthetic maintenance concentration not equal to 0.5 MAC\n* Known allergy to propofol or remifentanil\n* Severe obesity (BMI \\>= 35 kg\u002Fm2)\n* Severe cardiovascular disease (NYHA class IV heart failure, unstable angina, or recent myocardial infarction within 30 days)\n* Participation in another interventional clinical trial within 30 days","ALL","18 Years","85 Years",{"count":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"NA","This proof-of-concept randomized controlled trial evaluates a reinforcement learning (RL)-based clinical decision support system for intraoperative hemodynamic management during non-cardiac surgery.\n\nBackground: Intraoperative hypotension is common during general anesthesia and is associated with adverse outcomes including acute kidney injury, myocardial injury, and increased mortality. Current hemodynamic management relies on the individual anesthesiologist's clinical judgment, which can vary in consistency and timeliness. An RL-based system that learns optimal vasoactive agent dosing strategies from clinical data may help standardize and improve real-time hemodynamic decision-making.\n\nPurpose: The primary objective is to evaluate whether the RL-based decision support system can learn intraoperative hemodynamic management decisions comparable to those of experienced anesthesiologists, as measured by the mean absolute error (MAE) between RL-recommended and clinician-executed vasoactive agent doses. The secondary objective is to assess whether RL-guided management improves clinical hemodynamic outcomes, including the time-weighted average of hypotension and the percentage of time with mean arterial pressure within the target range.\n\nParticipants: Adult patients (aged 18 to 85 years, ASA I-IV) scheduled for elective non-cardiac surgery under general anesthesia with continuous invasive arterial blood pressure monitoring.\n\nProcedures: Participants will be randomly assigned (1:1) to one of two groups. In the RL-guided group, the anesthesiologist will receive real-time vasoactive agent dosing recommendations from the decision support system displayed on a bedside screen; the anesthesiologist retains full clinical autonomy over all final decisions. In the standard care group, the anesthesiologist will manage hemodynamics according to institutional standard practice without input from the system. The patient and the outcomes assessor will be masked to group assignment. Data collection covers the intraoperative period and 30-day postoperative follow-up.",[94,95],"Intraoperative Hypotension","Hemodynamic Instability",[97,98,99,100,101],"Reinforcement Learning","Clinical Decision Support System","Depth of Anesthesia","Artificial Intelligence","Vasoactive Agent Dosing","NOT_YET_RECRUITING","2026-04-01",{"date":105,"type":106},"2026-04-06","ACTUAL",{"date":108,"type":88},"2026-06-01",{"date":110,"type":88},"2027-12-15",{"name":5,"class":6},2]