[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599206":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":26},{"fullName":5,"class":6},"The First People's Hospital of Lianyungang","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"During anesthesia induction, ciprofol 0.2-0.5 mg\u002Fkg was intravenously injected (injection rate > 30s","EXPERIMENTAL","Group C",[13],"Drug: Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients",{"label":15,"type":16,"description":17,"interventionNames":18},"During anesthesia induction, propofol 1-2 mg\u002Fkg was intravenously injected (injection rate > 30s).","ACTIVE_COMPARATOR","Group P",[19],"Drug: Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravenous Anesthetic Induction with Ciprofol for Painless Colonoscopy in Elderly Patients","Cirpropofol is a 2,6-disubstituted phenol derivative that introduces a cyclopropyl group based on the chemical structure of propofol, increasing its affinity with GABA receptors and stereoeffect, thus its effect is 4-5 times that of propofol. Studies have found that the incidence of hypotension, injection pain, and respiratory depression during cirpropofol anesthesia is lower than that of propofol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Propofol Intravenous Anesthesia Induction for Painless Colonoscopy in Elderly Patients","Propofol has favorable pharmacokinetic properties with minimal residue. Currently, it is widely used for endoscopic procedure sedation, but there are still many limitations, such as a narrow therapeutic window, injection pain, hypotension, and respiratory depression.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"zhibin Zhao","CONTACT","18961326661","lygzhaozhibin@163.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100599206","ciprofols-influence-on-lvot-vti-in-elderly-painless-colonoscopy-patients-100599206",false,"NCT07081477","Ciprofol's Influence on LVOT VTI in Elderly Painless Colonoscopy Patients","Effect of Ciprofol on Left Ventricular Outflow Tract Velocity-Time Integral in Elderly Patients Undergoing Painless Colonoscopy","Inclusion Criteria:\n\n1. ASA classification I-III;\n2. Age ≥65 years and ≤80 years;\n3. BMI between 18-30 kg\u002Fm2 (including the threshold);\n4. Patients undergoing painless colonoscopy on an elective basis;\n5. Subjects voluntarily participated in this study and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Those with respiratory depression or high risk of respiratory depression (e.g., sleep apnea syndrome, bronchial asthma, etc.);\n2. Suffering from major diseases such as severe hepatic and renal insufficiency, neurological and psychiatric systems;\n3. Suffering from severe arrhythmias such as severe aortic regurgitation, atrial fibrillation, tachycardia (heart rate \\> 120 beats\u002Fminute), atrioventricular block of degree II and above, myocardial infarction or unstable angina within 6 months before the examination, and NYHA classification grade II and above;\n4. Allergy to or abuse of any medication used in the study;\n5. Participation in another clinical trial within the last 3 months.",true,"ALL","65 Years","80 Years",{"count":51,"type":52},120,"ESTIMATED","INTERVENTIONAL",[55],"NA","1. Objective:\n\n   Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (≥65 years).\n\n   Secondary: Assess hypotension incidence, injection pain, nausea\u002Fvomiting, hypoxia (SpO₂≤90%), bradycardia (HR\\\u003C50 bpm), sedation success rate, induction\u002Frecovery times, procedure duration, drug doses, and patient satisfaction.\n2. Design:\n\n   Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg\u002Fkg IV induction (\\>30s injection). Group P (Propofol)::1-2 mg\u002Fkg IV induction (\\>30s injection). Rescue doses allowed (C: 0.1 mg\u002Fkg; P: 0.5 mg\u002Fkg; max 5 doses\u002F15 min).\n3. Participants:\n\n   N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg\u002Fm²) scheduled for elective painless colonoscopy.\n\n   Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI\u002Funstable angina (≤6 months); NYHA ≥II; drug allergies; recent trial participation.\n4. Key Assessments:\n\n   Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1.\n\n   Secondary Endpoints:\n\n   Adverse events (hypotension, pain, nausea\u002Fvomiting, hypoxia, bradycardia, body movement, awareness).\n\n   Sedation success rate, induction\u002Frecovery times (MOAA\u002FS scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO₂).\n5. Statistical Analysis:\n\nSPSS 26.0; α=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square\u002FFisher's exact, rank-sum tests.\n\nThis study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.",[58],"Ciprofol",[60,61,62],"Painless colonoscopy","Propofol","Left Ventricular Outflow Tract Velocity Time Integral","NOT_YET_RECRUITING","2025-07-15",{"date":66,"type":67},"2025-07-23","ACTUAL",{"date":69,"type":52},"2025-08-25",{"date":71,"type":52},"2027-06-30",{"name":5,"class":6}]