[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511225":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":80,"collaborators":27,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":27,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":27,"enrollmentInfo":91,"targetDuration":27,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":27,"overallStatus":54,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Gangnam Severance Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"EEG-and-ANI-guided group","EXPERIMENTAL","During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.",[13,14,15],"Procedure: EEG-and-ANI-guided anesthesia","Drug: Sevoflurane and remifentanil","Device: EEG and ANI",{"label":17,"type":18,"description":19,"interventionNames":20},"Usual care group","ACTIVE_COMPARATOR","During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.",[21,14],"Procedure: standard anesthesia",[23,28,31,36],{"type":24,"name":25,"description":11,"armGroupLabels":26,"otherNames":27},"PROCEDURE","EEG-and-ANI-guided anesthesia",[9],null,{"type":24,"name":29,"description":19,"armGroupLabels":30,"otherNames":27},"standard anesthesia",[17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"DRUG","Sevoflurane and remifentanil","For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.",[9,17],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"DEVICE","EEG and ANI","EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.",[9],[42],{"name":43,"affiliation":5,"role":44},"Dong Woo Han, MD,PhD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Sun-Kyung Park, MD,PhD","CONTACT","821024505924","mayskpark@gmail.com",[52,71],{"facility":53,"status":54,"city":55,"state":27,"zip":56,"country":57,"countryCode":27,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"GangnamSeverance Hospital","RECRUITING","Seoul","06230","South Korea",{"type":59,"coordinates":60},"Point",[61,62],126.9784,37.566,{"lat":62,"lon":61},[65,67],{"name":66,"role":48,"phone":27,"phoneExt":27,"email":27},"Sun-kyung Park",{"name":68,"role":48,"phone":69,"phoneExt":27,"email":70},"Dong Woo Han","82-2-2450-5924","mayskpark@yuhs.ac",{"facility":5,"status":72,"city":55,"state":27,"zip":27,"country":57,"countryCode":27,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"NOT_YET_RECRUITING",{"type":59,"coordinates":74},[61,62],{"lat":62,"lon":61},[77],{"name":78,"role":48,"phone":79,"phoneExt":27,"email":70},"Sun-Kyung Park, MD, PhD","82-10-2450-5924",{"type":44,"investigatorFullName":68,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Professor","100511225","eeg-and-ani-guided-anesthesia-and-quality-of-recovery-100511225",false,"NCT05936671","EEG and ANI Guided Anesthesia and Quality of Recovery","Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\nAdult female patients who are scheduled to undergo laparoscopic gynecological surgery.\n\n1. Total laparoscopic hysterectomy with\u002Fwithout salpingo-oophorectomy\n2. Laparoscopic myomectomy\n3. Laparoscope-guided salpingo-oophorectomy\n4. Laparoscope-guided ovarian cystectomy\n5. Laparoscope-guided enucleation of ovarian cyst\n\nExclusion Criteria:\n\n1. Patients with nonregular sinus cardiac rhythm\n2. Patients with implanted pacemakers\n3. Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents\n4. pregnant or breastfeeding women\n5. Patients who are unable to communicate","FEMALE","19 Years",{"count":92,"type":93},126,"ESTIMATED","INTERVENTIONAL",[96],"NA","This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Patients will be randomly assigned to either EEG and Analgesia Nociception Index (ANI)-guided anesthesia group (EEG-and-ANI-Guided group) or usual care group (control group). Primary outcome is 15-item Quality of Recovery (QoR-15) score at postoperative day (POD) 1. Secondary outcomes included remifentanil consumption during anesthesia, occurrence of awareness with recall, incidence of undesirable intraoperative movement, emergence time, postoperative pain scores, quality of recovery score at POD 2, and length of hospital stay.",[99],"Laparoscopic Gynecological Surgery","2024-08-14",{"date":102,"type":103},"2024-08-15","ACTUAL",{"date":105,"type":103},"2023-07-13",{"date":107,"type":93},"2025-06-25",{"name":5,"class":6},2]