[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645059":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":33,"armGroups":37,"interventions":44,"overallOfficials":33,"centralContacts":50,"locations":59,"responsibleParty":77,"collaborators":33,"id":81,"slug":33,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":33,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":33,"enrollmentInfo":89,"targetDuration":33,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":105,"whyStopped":33,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy","The 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol 2 mg\u002Fkg to fully suppress positive responses during gastroscopy insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as body movement, cough, or blood pressure\u002Fheart rate elevation exceeding 20% compared with baseline within 3 minutes after gastroscopy placement. Subjects are divided into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 estimation.","Within 3 minutes after gastroscopy insertion",[14,18],{"measure":15,"description":16,"timeFrame":17},"Changes in blood pressure at predefined time points","Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) are recorded at: Baseline (prior to tegileridine administration) ,2 minutes after tegileridine bolus, Immediately before gastroscopy insertion, The highest values within 3 minutes following insertion","From baseline through 3 minutes after gastroscopy insertion.",{"measure":19,"description":20,"timeFrame":17},"Heart rate at predefined time points","Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before gastroscopy insertion, and the peak value within 3 minutes after insertion.",[22,26],{"measure":23,"description":24,"timeFrame":25},"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.","2 minutes after intravenous anesthetic injection",{"measure":27,"description":28,"timeFrame":29},"Incidence of perioperative adverse events","Proportion of participants experiencing adverse events including hypotension, bradycardia, arrhythmia, palpitations, dizziness, hypersensitivity, nausea and vomiting, respiratory depression during sedation and within 24 hours after gastroscopy","From anesthesia induction to 24 hours after gastroscopy",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":33,"timePerspective":33,"maskingInfo":35},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":36,"maskingDescription":33,"whoMasked":33},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Single Group (All Adult Patients Aged ≥18 Years)","EXPERIMENTAL","All enrolled adult patients receive variable-dose intravenous tegileridine adjusted by biased-coin up-and-down sequential design plus fixed-dose propofol 2 mg\u002Fkg for sedation during painless gastroscopy. Patients are stratified into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 analysis.",[43],"Drug: Tegileridine combined with Propofol for gastroscopy",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"DRUG","Tegileridine combined with Propofol for gastroscopy","All participants receive intravenous tegileridine with dose adjusted by biased-coin up-and-down sequential design, combined with fixed-dose propofol 2 mg\u002Fkg for anesthesia induction before painless gastroscopy. The initial dose of tegileridine is 5 μg\u002Fkg, with a 1 μg\u002Fkg step for dose increment or decrement according to gastroscopy insertion response. Subjects are stratified into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 calculation.",[39],[51,56],{"name":52,"role":53,"phone":54,"phoneExt":33,"email":55},"Shiyou W Wei","CONTACT","+86 15601680288","lovewishyou@tongji.edu.cn",{"name":57,"role":53,"phone":33,"phoneExt":33,"email":58},"Jianmang Y Yu","yujianmang@hbust.edu.cn",[60],{"facility":61,"status":33,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology","Tianmen","Hubei","431700","China","CN",{"type":68,"coordinates":69},"Point",[70,71],113.15369,30.65888,{"lat":71,"lon":70},[74],{"name":75,"role":53,"phone":76,"phoneExt":33,"email":58},"Jianmang Yu","+8613094293728",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Shiyou Wei","Department of Anesthesiology","100645059",false,"NCT07678411","ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy","Determination of The 90% Effective Dose of Tegileridine Combined With Propofol for Gastroscopy in Patients of Different Ages: A Biased-Coin Up-and-down Design Study","Inclusion Criteria:\n\n* Outpatients scheduled for elective painless gastroscopy\n* Age ≥ 18 years old\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Body mass index (BMI) between 18.5 and 29.9 kg\u002Fm²\n\nExclusion Criteria:\n\n* Resting SBP ≥ 160 mmHg, DBP ≥ 110 mmHg, or heart rate ≥ 110 beats\u002Fmin on admission to endoscopy 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","ALL","18 Years",{"count":90,"type":91},108,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","This single-group, open-label, biased-coin up-and-down sequential dose-finding trial aims to determine the 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol to eliminate body movement, cough and excessive hemodynamic fluctuations during gastroscopy insertion in adult patients stratified into young (18-65 years) and elderly (≥65 years) subgroups. All subjects receive intravenous tegileridine followed by 2 mg\u002Fkg propofol for sedation induction. The initial tegileridine dose is 5 μg\u002Fkg with a 1 μg\u002Fkg dose step. Dose adjustment follows biased-coin algorithm: dose increases by 1 μg\u002Fkg if positive response occurs; if negative response, there is an 11% probability to decrease dose by 1 μg\u002Fkg. The trial will be terminated when 45 successful cases are accrued in each age subgroup. Primary outcome is ED90 of tegileridine calculated via central ordinal regression. Secondary outcomes include total propofol consumption, MOAA\u002FS sedation score, intraoperative blood pressure and heart rate changes, and incidence of perioperative adverse events within 24 hours post-procedure.",[97,98],"Painless Gastroscopy Perioperative Sedation","Upper Gastrointestinal Tract Lesions",[100,101,102,103,104],"Tegileridine","µ-opioid receptor G-protein-biased agonist","Biased-coin sequential allocation","gastroscopy","ED90","NOT_YET_RECRUITING","2026-06-25",{"date":108,"type":109},"2026-07-01","ACTUAL",{"date":111,"type":91},"2026-07-05",{"date":113,"type":91},"2026-07-27",{"name":79,"class":6},1]