[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650611":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":32,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":85,"whyStopped":32,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","All enrolled subjects receive intravenous tegileridine before anesthesia induction. The dose of tegileridine is adjusted sequentially for each subsequent subject following the biased coin up-and-down rule. General anesthesia and tracheal intubation are performed according to standardized protocol.",[13],"Drug: Tegileridine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tegileridine","Intravenous tegileridine administered prior to anesthesia induction. The initial dose and dose adjustment steps are predefined; individual dose will be modified by biased coin up-and-down sequential method to explore ED90 for inhibiting hemodynamic response to tracheal intubation.",[9],[21],"SHR8554",[23],{"name":24,"affiliation":25,"role":26},"Xin Lv, PhD","Shanghai Pulmonary Hospital, School of Medicine, Tongji University","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Shiyou Wei, Doc","CONTACT","15601680288",null,"lovewishyou@tongji.edu.cn",[35],{"facility":36,"status":32,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Shaoyang University Affiliated First Hospital","Shaoyang","Hunan","422000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],111.46214,27.23818,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":32,"email":52},"Yadan Liu, Doc","18229421255","lyd26897@163.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Shiyou Wei","Attending Physician, Department of Anesthesiology",[58],{"name":59,"class":60},"Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China","UNKNOWN","100650611","ed90-of-tegileridine-for-suppressing-hemodynamic-response-to-tracheal-intubation-a-biased-coin-up-and-down-trial-100650611",false,"NCT07749131","ED90 of Tegileridine for Suppressing Hemodynamic Response to Tracheal Intubation: A Biased Coin Up-and-Down Trial","Determination of the 90% Effective Dose (ED90) of Tegileridine Fumarate for Inhibiting Hemodynamic Stress Response Induced by Tracheal Intubation During General Anesthesia: A Biased Coin Up-and-Down Sequential Study","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Aged ≥18 ears old\n* Scheduled for elective surgery requiring general anesthesia with tracheal intubation\n\nExclusion Criteria:\n\n* Resting Systolic Blood Pressure ≥ 160 mmHg, Diastolic Blood Pressure ≥ 110 mmHg, or heart rate ≥ 110 beats\u002Fmin on admission to operation room\n* Continuous opioid medication use for more than 2 weeks within 6 months before the procedure\n* Known hypersensitivity or allergic reaction to tegileridine, propofol or any excipients of the two drugs\n* Diagnosed psychiatric disorders or inability to communicate and cooperate with study assessment\n* Anticipated difficult airway","ALL","18 Years","90 Years",{"count":72,"type":73},108,"ESTIMATED","INTERVENTIONAL",[76],"NA","General anesthesia tracheal intubation causes sympathetic activation and hemodynamic stress response, which increases perioperative cardiovascular risk, especially in elderly subjects. Tegileridine fumarate is a novel μ-opioid receptor G protein-biased agonist. However, the optimal dose of tegileridine to suppress intubation-induced hemodynamic fluctuations during anesthesia induction remains unclear.\n\nThis is an open-label, single-center, age-stratified biased coin up-and-down sequential trial. Subjects undergoing elective surgery requiring tracheal intubation will be divided into young adult group (18-64 years) and elderly group (≥65 years). The primary objective is to determine the ED90 of intravenous tegileridine for inhibiting hemodynamic response to tracheal intubation using centered isotonic regression. Secondary outcomes include investigational-drug adverse events, serial hemodynamic parameters. This study will provide evidence for rational dosing of tegileridine in clinical anesthesia induction.",[79,80,81],"Tracheal Intubation","Anesthesia, General","Hemodynamics",[17,83,84],"Hemodynamic Stress Response","ED90","NOT_YET_RECRUITING","2026-08-19",{"date":88,"type":89},"2026-08-21","ACTUAL",{"date":91,"type":73},"2026-09-01",{"date":93,"type":73},"2026-10-05",{"name":55,"class":6},1]