[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652828":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Interventional Arm","EXPERIMENTAL","All enrolled participants receive sufentanil citrate injection, infused via peripheral intravenous syringe pump during general anesthesia induction.\n\nTwo independent age-defined sequential sub-cohorts are included within this single arm:\n\n1. Younger adult sub-cohort (\\\u003C65 years): fixed sufentanil total dose 0.40 μg\u002Fkg actual body weight.\n2. Older adult sub-cohort (≥65 years): fixed sufentanil total dose 0.30 μg\u002Fkg actual body weight.\n\nWithin each sub-cohort, the sufentanil infusion time is adjusted sequentially by biased-coin up-and-down rule according to the previous participant's sufentanil-induced cough (SIC) outcome. No other prophylactic anti-cough medications are given during the SIC observation window. After completion of the observation period, standard general anesthesia induction will be performed according to institutional routine.",[13],"Drug: Sufentanil Citrate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sufentanil Citrate","Sufentanil citrate administered via peripheral intravenous syringe pump during general anesthesia induction. Fixed weight-based total dose within each age sub-cohort; infusion time varies according to biased-coin up-and-down sequential rules.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Xin Lv","Shanghai Pulmonary Hospital, School of Medicine, Tongji University","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Shiyou Wei, Doc","CONTACT","15601680288","lovewishyou@tongji.edu.cn",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Shaoyang University Affiliated First Hospital","Shaoyang","Hunan","422000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],111.46214,27.23818,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":20,"email":50},"Yadan Liu","18229421255","lyd26897@163.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Shiyou Wei","Attending Physician, Department of Anesthesiology",[56],{"name":57,"class":58},"Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China","UNKNOWN","100652828","90-effective-infusion-time-of-sufentanil-to-prevent-induction-cough-a-biased-coin-sequential-study-100652828",false,"NCT07778953","90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study","Determination of the 90% Effective Infusion Time of Sufentanil to Prevent Sufentanil-Induced Cough During General Anesthesia Induction in Young and Elderly Patients: A Biased Coin Design 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 vital signs upon operating-room arrival: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg, or heart rate ≥110 beats per minute.\n* Anticipated difficult airway, requirement for rapid-sequence induction, or emergency surgery.\n* Chronic cough, asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, active pulmonary disease, or upper respiratory tract infection within the preceding 2 weeks.\n* Regular opioid use for more than 2 weeks within 6 months before surgery; or recent use of antitussive agents or other medications that may alter the cough reflex.\n* Known history of allergy to study drug (sufentanil citrate).\n* Pregnancy, lactation, psychiatric disorders, or individuals unable to communicate appropriately.","ALL","18 Years","99 Years",{"count":70,"type":71},120,"ESTIMATED","INTERVENTIONAL",[74],"NA","This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (\\\u003C65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective.\n\nAll participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg\u002Fkg; elderly: 0.30 μg\u002Fkg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends.\n\nThe primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.",[77],"Cough",[79,80,81,82],"sufentanil-induced cough","general anesthesia induction","endotracheal intubation","infusion time","NOT_YET_RECRUITING","2026-08-19",{"date":86,"type":87},"2026-08-21","ACTUAL",{"date":89,"type":71},"2026-11-01",{"date":91,"type":71},"2026-12-30",{"name":53,"class":6},1]