[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564094":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":74,"collaborators":78,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The penehyclidine hydrochloride group","EXPERIMENTAL","Inhaling penehyclidine hydrochloride (a dose of 0.05 mg\u002Fkg, diluted and mixed with normal saline to a total volume of 5 ml) for nebulization therapy within 30 min prior to surgery.",[13],"Drug: Penehyclidine hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"The normal saline group","PLACEBO_COMPARATOR","Inhaling normal saline in a total volume of 5 ml for nebulization therapy within 30 min prior to surgery.",[19],"Drug: Normal Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Penehyclidine hydrochloride","The penehyclidine hydrochloride will be diluted to a total volume of 5 mL with normal saline, added to the nebulizer cup for inhalation. Patients will be asked to inhale the entire volume of nebulized drugs within 30 min prior to surgery. The trial drugs will be administered using a jet nebulizer with compressed air flow. Each child will be intructed to begin the nebulization by using a face mask that covers the nose and mouth while the child is seated upright. Children will be encouraged to take deep and slow breaths, inhaling through the mouth and exhaling through the nose, to ensure the drugs effectively reaches the airway.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline","The normal saline with a total volume of 5 mL will be added to the nebulizer cup for inhalation. Patients will be asked to inhale the entire volume of nebulized drugs within 30 min prior to surgery. The trial drugs will be administered using a jet nebulizer with compressed air flow. Each child will be intructed to begin the nebulization by using a face mask that covers the nose and mouth while the child is seated upright. Children will be encouraged to take deep and slow breaths, inhaling through the mouth and exhaling through the nose, to ensure the drugs effectively reaches the airway.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiaoliang Gan, PhD","CONTACT","86+13688893908","ganxl@mail.sysu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Yanling Zhu, MD","86+18898600243","zhuyling8@mail.sysu.edu.cn",[42,60],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Zhongshan Ophthalmic Center, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.25,23.11667,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":36},"Xiaoliang Gan, MD., PhD.","86-020-8733-1548",{"facility":61,"status":44,"city":62,"state":46,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Shenzhen Eye Hospital","Shenzhen","518040",{"type":51,"coordinates":65},[66,67],114.0683,22.54554,{"lat":67,"lon":66},[70],{"name":71,"role":34,"phone":72,"phoneExt":26,"email":73},"Dongsheng Zhao, MD.","86-0755-2395-9510","13688808920@139.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":43,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xiaoliang Gan","The head of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University",[79],{"name":61,"class":6},"100564094","phase-4-inhaling-penehyclidine-to-prevent-perioperative-respiratory-adverse-events-in-children-at-risk-undergoing-sevoflurane-anesthesia-100564094",false,"NCT06624696","Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia","Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia: a Double-blind, Randomized, Placebo-controlled Trial","PEPSI","Inclusion Criteria:\n\n1. Pediatric patients aged 3 to 7 years.\n2. Scheduled to undergo ophthalmic surgery.\n3. Judged to be at risk of PRAEs (with at least one parentally reported risk factor for the PRAEs, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke).\n\nExclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) physical classification ≥ IV.\n2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).\n3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);\n4. Neurological disorders.\n5. Neuromuscular diseases.\n6. Contraindication for PHC.\n7. Inhalation of β2-receptor activator, M-receptor blockers and\u002For glucocorticoids within 1 month before surgery.\n8. Allergy to anticholinergic drugs.\n9. Use of endotracheal tube (ETT) for ventilation.\n10. Known difficult airway.\n11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.\n12. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.\n13. Parents refusing to allow their children to participate.\n14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.","ALL","3 Years","7 Years",{"count":92,"type":93},204,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This randomized controlled study is to evaluate the effectiveness of inhaling penehyclidine hydrochloride in reducing perioperative respiratory adverse events in children at risk undergoing minor elective surgery.",[99,100,101,102,103],"Respiratory Hypersensitivity","Perioperative Respiratory Adverse Events","Anticholinergics","Inhalation Therapy; Complications","High Risk",[105,106,107,108],"perioperative respiratory adverse events","pediatric anesthesia","penehyclidine","sevoflurane","2026-04-09",{"date":111,"type":112},"2026-04-14","ACTUAL",{"date":114,"type":112},"2024-11-12",{"date":116,"type":93},"2026-09-30",{"name":5,"class":6},2]