[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616102":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":32,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Shanghai Geriatric Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Elderly Orthopedic Limb Surgery Cohort",null,"Inclusion Criteria:\n\nAge ≥65 years; BMI 18-30 kg\u002Fm²; ASA physical status classification I-III; Scheduled for elective orthopedic limb surgery under general anesthesia; Expected duration of surgery \\>30 minutes; Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\nKnown allergy to ciprofol or related medications, or any contraindication to their use; Preoperative cognitive impairment (Mini-Cog score \\\u003C3); History of severe cerebrovascular disease or related complications; History of neuromuscular system diseases or psychiatric disorders; History of sedative medication use; History of alcohol abuse or substance use disorder; Bradycardia (heart rate \\\u003C60 beats per minute); Hypotension (mean arterial pressure \\\u003C55 mmHg); QT interval prolongation; Uncooperative or unable to communicate effectively.",[13],"Drug: Ciprofol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ciprofol","Ciprofol is used as an intravenous anesthetic agent for sedation and anesthesia induction\u002Fmaintenance in elderly patients undergoing elective orthopedic limb surgery. In this observational study, ciprofol is administered according to standard clinical practices, and data on its pharmacokinetics, pharmacodynamics, safety, and effectiveness in this specific population will be collected.",[9],[21,22],"Cipepofol","Sishuning",[24],{"name":25,"affiliation":5,"role":26},"Xue Zhang","PRINCIPAL_INVESTIGATOR",[28],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","02164175590","zx02190554@126.com",[33],{"facility":5,"status":34,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":47,"phoneExt":10,"email":31},"Clinical Research Coordinator","021-64175590",{"type":26,"investigatorFullName":25,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Attending Physician","100616102","population-pharmacokinetics-and-pharmacodynamics-of-ciprofol-100616102",false,"NCT07301242","Population Pharmacokinetics and Pharmacodynamics of Ciprofol","Population Pharmacokinetic\u002FPharmacodynamic Modeling of Ciprofol in Elderly Patients Undergoing Orthopedic Limb Surgery","Inclusion Criteria:\n\n* Age ≥65 years;\n* BMI: 18-30 kg\u002Fm²;\n* ASA physical status classification I-III;\n* Scheduled for elective orthopedic limb surgery under general anesthesia;\n* Expected duration of surgery \\>30 minutes;\n* Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to ciprofol or related medications, or any contraindication to their use;\n* Preoperative cognitive impairment;\n* History of severe cerebrovascular disease or related complications;\n* History of neuromuscular system diseases or psychiatric disorders;\n* History of sedative medication use;\n* History of alcohol abuse or substance use disorder;\n* Bradycardia (heart rate \\\u003C60 beats per minute);\n* Hypotension (mean arterial pressure \\\u003C55 mmHg);\n* QT interval prolongation;\n* Uncooperative or unable to communicate effectively.","ALL","65 Years",{"count":60,"type":61},50,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how the anesthetic drug ciprofol works in older adults who are having limb surgery under general anesthesia at Shanghai Geriatric Medical Center. The study will help researchers build a population model to better understand how the drug moves through the body (PK) and how it affects patients (PD). This model may help doctors use a Target-Controlled Infusion (TCI) system to adjust the drug dose more precisely.\n\nThe main question it aims to answer is: Does ciprofol work safely and effectively in older adults during orthopedic surgery?\n\nParticipants already receiving ciprofol as part of their regular anesthesia care will:\n\n1. Provide blood samples at different time points during and after surgery.\n2. Have their vital signs and anesthesia-related data recorded before, during, and after surgery.\n3. Be monitored for side effects and recovery indicators such as the Aldrete score and signs of postoperative delirium.\n\nResearchers will use this information to:\n\n1. Build and test a population PK\u002FPD model for ciprofol.\n2. Simulate recommended TCI dosing plans.\n3. Explore how individual responses to ciprofol relate to recovery and safety outcomes.\n\nThis study may help improve anesthesia care for elder adults by making drug dosing safer and more effective.",[65,66,67],"Hip Fractures (ICD-10 72.01-72.2)","Osteoarthritis, Knee and Hip","Femoral Neck Fractures","2025-12-10",{"date":70,"type":71},"2025-12-24","ACTUAL",{"date":73,"type":71},"2025-10-28",{"date":75,"type":61},"2026-12",{"name":5,"class":6},1]