[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578813":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":36,"locations":44,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"group P（Propofol group）","EXPERIMENTAL","Patients were assigned to group P (Propofol group) using a computer-generated random number table",[13],"Drug: Propofol group",{"label":15,"type":10,"description":16,"interventionNames":17},"group R (Remimazolaml group)","Patients were assigned to group R (Remimazolaml group) using a computer-generated random number table",[18],"Drug: Remimazolam group",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Propofol group","Induction phase: Administer fentanyl at a dose of 2-3 mcg\u002Fkg, and after 3 minutes, administer propofol intravenously at a dose of 2.0 mg\u002Fkg.\n\nMaintenance phase: Infuse propofol (4-12 mg\u002Fkg\u002Fh) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg\u002Fkg\u002Fmin. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml\u002Fkg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml\u002Fkg; lower abdomen\u002Finguinal area: 0.25% ropivacaine 0.75 ml\u002Fkg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Remimazolam group","Induction phase: Administer fentanyl at a dose of 2-3 mcg\u002Fkg, and after 3 minutes, administer remimazolam intravenously at a dose of 0.45-0.55 mg\u002Fkg.\n\nMaintenance phase: Infuse remimazolam (1-3 mg\u002Fkg\u002Fh) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg\u002Fkg\u002Fmin. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml\u002Fkg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml\u002Fkg; lower abdomen\u002Finguinal area: 0.25% ropivacaine 0.75 ml\u002Fkg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.",[15],[31,34],{"name":32,"affiliation":5,"role":33},"Huacheng Liu","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Yuhang Cai",[37,41],{"name":32,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","18957755138","huachengliu@163.com",{"name":35,"role":38,"phone":42,"phoneExt":25,"email":43},"18815091585","838097626@qq.com",[45],{"facility":46,"status":25,"city":47,"state":48,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","China","CN",{"type":52,"coordinates":53},"Point",[54,55],120.66682,27.99942,{"lat":55,"lon":54},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100578813","phase-4-effect-of-propofol-versus-remimazolam-intravenous-anesthesia-on-respiratory-depression-100578813",false,"NCT06816173","Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression","Effect of Propofol Versus Remimazolam Intravenous Anesthesia Combined With Regional or Caudal Block on Respiratory Depression in Young Children: A Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. Aged 3-6 years, gender unrestricted;\n2. American Society of Anesthesiologists (ASA) physical status classification of I-II;\n3. Body Mass Index (BMI) between 14 kg\u002Fm² and 25 kg\u002Fm²;\n4. Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;\n5. The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Children requiring special care or under the supervision of a court or social welfare agency;\n2. Children who have received general anesthesia within 3 months prior to the screening period;\n3. Children with a history of respiratory diseases within the past 2 weeks or those deemed to have difficult airway management: Modified Mallampati score of III or IV;\n4. Children with severe cardiovascular diseases or endocrine system abnormalities;\n5. Children with known psychiatric disorders or cognitive impairments;\n6. Children with abnormal liver function, ALT (alanine aminotransferase) and\u002For AST (aspartate aminotransferase) \\>1.5 times the upper limit of normal; children with total bilirubin exceeding the upper limit of normal; children with abnormal kidney function, creatinine and\u002For blood urea nitrogen higher than the upper limit of normal;\n7. Children known or suspected to be allergic to the study drug or benzodiazepines.",true,"ALL","3 Years","6 Years",{"count":71,"type":72},96,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.",[78],"Respiratory Depression","NOT_YET_RECRUITING","2025-02-04",{"date":82,"type":83},"2025-02-10","ACTUAL",{"date":85,"type":72},"2025-02",{"date":87,"type":72},"2026-02",{"name":5,"class":6},1]