[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535451":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Shanghai 6th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"fospropofol","EXPERIMENTAL",null,[13],"Drug: fospropofol sedation",{"label":15,"type":16,"description":11,"interventionNames":17},"propofol","PLACEBO_COMPARATOR",[18],"Drug: Propofol",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","fospropofol sedation","Fospropofol sedation for same-day bidirectional endoscopy in elderly patients",[9],{"type":21,"name":26,"description":15,"armGroupLabels":27,"otherNames":11},"Propofol",[15],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Xiaofeng WANG","Principal investigator","100535451","phase-4-efficacy-and-safety-of-fospropofol-for-same-day-bidirectional-endoscopy-in-elderly-patients-100535451",false,"NCT06251999","Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients","Efficacy and Safety of Fospropofol Disodium Sedation for Same-day Bidirectional Endoscopy in Elderly Patients: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Trial","Inclusion Criteria:\n\n* 65 years or older\n* American Society of Anesthesiologists (ASA) physical status I to III\n* Body mass index (BMI) 18-30 kg\u002Fm2\n* Scheduled for same-day bidirectional endoscopy under sedation\n\nExclusion Criteria:\n\n* Severe cardiovascular, pulmonary, renal, or liver diseases\n* Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate \\\u003C50 beats\u002Fmin), or hypoxemia (SpO2 \\\u003C90%)\n* Neurocognitive or psychiatric disorders\n* Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)\n* Hypersensitivity to study medications\n* Drug or alcohol misuse\n* Definite upper respiratory tract infection\n* Refusal for participation","ALL","65 Years",{"count":42,"type":43},256,"ESTIMATED","INTERVENTIONAL",[46],"PHASE4","Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.\n\nMethods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg\u002Fkg or 1.5 mg\u002Fkg propofol and supplemental doses of fospropofol 1.6 mg\u002Fkg or 0.5 mg\u002Fkg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 \\\u003C 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis.\n\nDiscussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.",[49],"Elderly Patients",[9,15,51,52,53],"sedation","elderly","bidirectional endoscopy","NOT_YET_RECRUITING","2024-02-08",{"date":57,"type":58},"2024-02-09","ACTUAL",{"date":60,"type":43},"2024-08-01",{"date":62,"type":43},"2028-08-31",{"name":5,"class":6}]