[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644147":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":37,"armGroups":40,"interventions":47,"overallOfficials":37,"centralContacts":53,"locations":63,"responsibleParty":79,"collaborators":37,"id":83,"slug":37,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":37,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":37,"enrollmentInfo":91,"targetDuration":37,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":106,"whyStopped":37,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response","The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure\u002Fheart rate increase over 20% compared with baseline within 3 minutes after LMA placement.","Within 3 minutes after laryngeal mask airway insertion",[14,18],{"measure":15,"description":16,"timeFrame":17},"Incidence of cough during laryngeal mask airway insertion","During anesthesia induction, intravenous injection of opioids may cause coughing. During the after laryngeal mask airway insertion process, coughing may occur due to airway stimulation.","From the start of anesthesia induction to 3 minutes after the end of laryngeal mask airway insertion",{"measure":19,"description":20,"timeFrame":21},"Success rate of sedation","The modified observer's assessment of alert\u002Fsedation scale (MOAA\u002FS) is a commonly - used sedation evaluation tool in clinical practice. It classifies reactivity under different stimuli: Grade 5 means a sensitive response to calling the name in a normal tone of voice; Grade 4 indicates a sluggish response to calling the name in a normal tone of voice; Grade 3 requires a loud or repeated call of the name to elicit a response; Grade 2 shows a response to slight pushing and vibration; Grade 1 has a response to a painful stimulus (by squeezing the trapezius muscle area); Grade 0 means no response to a painful stimulus. Moreover, MOAA\u002FS ≤ 2 indicates loss of consciousness, which can assist medical staff in judging the sedation level and consciousness state of patients.","From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion",[23,27,30],{"measure":24,"description":25,"timeFrame":26},"Changes in blood pressure at predefined time points","Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) are recorded at:\n\nBaseline (prior to tegileridine administration) ,2 minutes after tegileridine bolus, Immediately before laryngeal mask airway insertion, The highest values within 3 minutes following insertion","From baseline through 3 minutes after laryngeal mask airway insertion.",{"measure":28,"description":29,"timeFrame":26},"Heart rate at predefined time points","Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before laryngeal mask airway insertion, and the peak value within 3 minutes after insertion.",{"measure":31,"description":32,"timeFrame":33},"Incidence of perioperative adverse events","The proportion of participants with perioperative adverse reactions including hypotension, bradycardia, arrhythmia, palpitations, dizziness, hypersensitivity, nausea and vomiting, laryngospasm, pruritus, respiratory depression. All adverse events from anesthesia induction to 24 hours postoperatively will be recorded.","From anesthesia induction to 24 hours after surgery",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":6,"observationalModel":37,"timePerspective":37,"maskingInfo":38},"NA","SEQUENTIAL",null,{"masking":39,"maskingDescription":37,"whoMasked":37},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Single Group (All Adult Patients Aged ≥18 Years)","EXPERIMENTAL","All enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg\u002Fkg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg\u002Fkg, with 1 μg\u002Fkg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-65 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects.",[46],"Drug: Tegileridine combined with Propofol for anesthesia induction",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":37},"DRUG","Tegileridine combined with Propofol for anesthesia induction","Intravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg\u002Fkg for general anesthesia induction before laryngeal mask airway placement.",[42],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":37,"email":58},"Shiyou W Wei","CONTACT","+86 15601680288","lovewishyou@tongji.edu.cn",{"name":60,"role":56,"phone":61,"phoneExt":37,"email":62},"Jianmang Y Yu","+8613094293728","yujianmang@hbust.edu.cn",[64],{"facility":65,"status":37,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology","Tianmen","Hubei","431700","China","CN",{"type":72,"coordinates":73},"Point",[74,75],113.15369,30.65888,{"lat":75,"lon":74},[78],{"name":60,"role":56,"phone":61,"phoneExt":37,"email":62},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","Shiyou Wei","Department of Anesthesiology","100644147",false,"NCT07665151","ED90 of Tegileridine Combined With Propofol for LMA Insertion","90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study","Inclusion Criteria:\n\n* Elective surgery requiring general anesthesia with laryngeal mask airway insertion\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm\n* Continuous opioid medication for more than 2 weeks within half a year before surgery\n* Known allergy or hypersensitivity to tegileridine or any study medication components\n* History of psychiatric illness or inability to communicate effectively","ALL","18 Years",{"count":92,"type":93},108,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-65 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure\u002Fheart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.",[99],"Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia",[101,102,103,104,105],"Tegileridine","µ-opioid receptor G-protein-biased agonist","laryngeal mask airway","Biased-coin sequential allocation","ED90","NOT_YET_RECRUITING","2026-06-24",{"date":109,"type":110},"2026-06-29","ACTUAL",{"date":112,"type":93},"2026-07-10",{"date":114,"type":93},"2026-08-10",{"name":81,"class":6},1]