[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644503":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":32,"studyPopulation":20,"armGroups":33,"interventions":46,"overallOfficials":20,"centralContacts":55,"locations":65,"responsibleParty":79,"collaborators":20,"id":81,"slug":20,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":20,"eligibilityCriteria":85,"healthyVolunteers":82,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":99,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"General Hospital of Ningxia Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Comparison of hemodynamic and respiratory function changes within 5 minutes of anesthesia induction","The primary objective of this study was to evaluate the degree of circulatory and respiratory suppression induced by two types of anesthesia drugs in elderly patients. Continuous, non-invasive monitoring was conducted on the baseline conditions before administration for patients aged 65 to 80 undergoing short procedures without intubation and with spontaneous respiration under general anesthesia. Additionally, measurements were taken at 1 minute, 2 minutes, 3 minutes, 4 minutes, and 5 minutes after induction to assess circulatory and respiratory functions. Statistical analysis was performed to compare the changes in HR, SBP, DBP, MAP, CO, SV, SVR, PETCO2, RR, and SPO2 within the 5-minute induction period. A comprehensive assessment of the dual safety of circulatory and respiratory systems was conducted","5 minutes after induction of anesthesia",[14,17],{"measure":15,"description":16,"timeFrame":12},"Brain electrical activity sedation depth (BIS)","lowest BIS value throughout the induction process, BIS value immediately upon loss of consciousness.",{"measure":18,"description":19,"timeFrame":12},"incidence of induction period circulatory\u002Frespiratory adverse events","Proportion of adverse events, including low blood pressure, bradycardia, inadequate ventilation, apnea, and hypoxemia, occurring within 5 minutes of induction",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"QUADRUPLE",[28,29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Inclusion Criteria\n\n1. Patients scheduled for elective non-intubated general anesthesia\n2. Age ranging from 65 to 80 years old\n3. American Society of Anesthesiologists (ASA) physical status class I-III\n4. Written informed consent signed by the patient or legal guardian\n\nExclusion Criteria\n\n1. Confirmed allergy to propofol, ciprofol or their excipients\n2. Severe cardiovascular diseases (uncontrolled hypertension, heart failure, severe arrhythmia, etc.)\n3. Severe respiratory diseases (chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, etc.)\n4. Severe hepatic or renal insufficiency\n5. Long-term regular use of sedatives or opioids\n6. Baseline bradycardia (HR \\\u003C 50 beats\u002Fmin) or hypoxemia (SpO₂ \\\u003C 90%) Elimination Criteria\n\n1\\. Patients with allergic reactions to study drugs or other severe complications during the trial\n\n2\\. Severe hypoxemia requiring emergency endotracheal intubation\n\n3\\. Severe hemodynamic instability occurring during induction\n\n4\\. Incomplete monitoring data caused by equipment malfunction Randomization and Group Allocation A total of 108 eligible elderly patients undergoing elective non-intubated general anesthesia at the Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University will be recruited. A computer-generated random number sequence will allocate subjects at a 1:1 ratio into the ciprofol group (Group C) and the propofol group (Group P).\n\nObservation Indicators\n\nBaseline Demographic Data\n\nGender, age, height, weight, BMI, ASA classification, smoking history, alcohol consumption, underlying diseases, Modified Mallampati score, thyromental distance, snoring history, etc.\n\nPrimary Observation Indicators\n\nHemodynamic parameters (HR, SBP, DBP, MAP, CO, SV, SVR) and respiratory parameters (SpO₂, respiratory rate (RR), PETCO₂) will be recorded at baseline, loss of consciousness, 30 s, 1 min, 2 min, 3 min, 4 min and 5 min after loss of consciousness.\n\nSecondary Observation Indicators\n\n1. Baseline BIS value and minimum BIS value during induction\n2. Total induction dosage, induction time (from drug administration to MOAA\u002FS ≤ 1), recovery time (from last drug administration to MOAA\u002FS = 5)\n3. Incidence of adverse reactions: injection pain, involuntary movement, hiccup, hypotension, bradycardia, hypoventilation, apnea, hypoxemia, etc.\n\nAnesthetic Protocol\n\nAll patients fast for 8 hours and abstain from clear liquids for 4 hours preoperatively. After entering the operating room, oxygen inhalation is initiated, upper limb venous access is established, and monitors including pulse oximetry, sidestream PETCO₂ monitor, continuous non-invasive arterial blood pressure monitor and bispectral index (BIS) monitor are connected.\n\nMidazolam 0.01 mg\u002Fkg is administered intravenously first; stable circulatory and respiratory readings thereafter serve as baseline values. Ciprofol or propofol is then infused intravenously at 10 mL\u002Fmin. Sedation depth is assessed every 5 seconds via MOAA\u002FS scale; drug infusion is stopped once MOAA\u002FS ≤ 1 (loss of consciousness). The total induction dose is recorded. All hemodynamic and respiratory indicators are documented at predefined time points.\n\nAnesthesiologists may supplement 1\u002F3 of the initial induction dose if the patient shows eye opening, verbal response or body movement, with an interval of at least 1 minute between supplemental doses.\n\nRescue Management Protocols\n\n* Hypotension (SBP \\\u003C 90 mmHg or MAP decreased by \\>20% from baseline lasting \\>2 min): ephedrine 6 mg IV\n* Severe bradycardia (HR \\\u003C 45 beats\u002Fmin lasting \\>30 s): atropine 0.5 mg IV\n* Hypoventilation (RR \\\u003C 8 bpm, PETCO₂ less than half baseline or PETCO₂ ≥45 mmHg lasting \\>30 s)\n* Apnea (no thoracic movement or flat PETCO₂ waveform lasting \\>10 s)\n* Hypoxemia (SpO₂ \\\u003C 93%) \u002F severe hypoxemia (SpO₂ \\\u003C 85%) For respiratory compromise, jaw thrust, increased oxygen flow or mask-assisted ventilation will be applied; emergency endotracheal intubation will be performed if necessary.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Ciprofol treatment group","EXPERIMENTAL","This group plans to enroll a total of 54 elderly patients aged 65-80 who will undergo brief procedures without intubation, using spontaneous respiration under general anesthesia. The intravenous infusion of cyclopropane hydrochloride injection will be administered at a constant rate of 10 ml\u002Fmin. The administration will cease when the MOAA\u002FS score is ≤1. Throughout the procedure, hemodynamic parameters (HR, SBP, DBP, MAP, CO, SV,SVR), and respiratory parameters (SpO₂, respiratory rate (RR), PETCO₂), and various anesthetic adverse reactions will be monitored within the first 5 minutes after induction. The safety of the medication will be evaluated in comparison with the control group",[39],"Drug: Ciprofol Injection",{"label":41,"type":42,"description":43,"interventionNames":44},"Propofol Control group","ACTIVE_COMPARATOR","This study aims to enroll 54 elderly patients aged 65-80 with short procedures and no need for intubation, who will receive propofol intravenously at a constant rate of 10 ml\u002Fmin until their MOAA\u002FS score drops to ≤1 point. Circulatory and respiratory parameters, as well as adverse events, will be recorded simultaneously 5 minutes after induction. This will allow for a parallel comparison of the two medications' effects on the circulatory and respiratory systems of elderly patients with the propofol control group.",[45],"Drug: Propofol Injection",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":20},"DRUG","Propofol Injection","Intravenous administration, injection rate of 10 ml\u002Fmin, continuous and uniform infusion until the patient's MOAA\u002FS sedation score is ≤1 point. This is used for the induction of general anesthesia in short-duration medical procedures for elderly individuals aged 65-80 without intubation and with spontaneous respiration",[41],{"type":48,"name":53,"description":50,"armGroupLabels":54,"otherNames":20},"Ciprofol Injection",[35],[56,61],{"name":57,"role":58,"phone":59,"phoneExt":20,"email":60},"Hanxiang Ma Ma, master","CONTACT","13519591508","mahanxiang@hotmail.com",{"name":62,"role":58,"phone":63,"phoneExt":20,"email":64},"LI Mo Mo, Bachelor","17752025907","ml185030153@163.com",[66],{"facility":67,"status":20,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":20},"Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University","Yinchuan","Ningxia","750000","China","CN",{"type":74,"coordinates":75},"Point",[76,77],106.27306,38.46806,{"lat":77,"lon":76},{"type":80,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100644503",false,"NCT07670923","Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia","Inclusion Criteria:\n\n1. Patients scheduled for elective non-intubated general anesthesia\n2. Age ranging from 65 to 80 years old\n3. American Society of Anesthesiologists (ASA) physical status class I-III\n4. Written informed consent signed by the patient or legal guardian\n\nExclusion Criteria:\n\n1. Confirmed allergy to propofol, ciprofol or their excipients\n2. Severe cardiovascular diseases (uncontrolled hypertension, heart failure, severe arrhythmia, etc.)\n3. Severe respiratory diseases (chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, etc.)\n4. Severe hepatic or renal insufficiency\n5. Long-term regular use of sedatives or opioids\n6. Baseline bradycardia (HR \\\u003C 50 beats\u002Fmin) or hypoxemia (SpO₂ \\\u003C 90%)","ALL","65 Years","80 Years",{"count":90,"type":91},108,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","At the initiation of induction for non-intubated general anesthesia, ciprofol or propofol will be administered intravenously at a rate of 10 mL\u002Fmin. The Modified Observer's Assessment of Alertness\u002FSedation (MOAA\u002FS) scale will be used to evaluate sedation depth. This study aims to assess the effects of ciprofol and propofol on hemodynamics and respiratory function in elderly patients undergoing non-intubated general anesthesia.",[84],[98],"Ciprofol; Propofol; Elderly patients; Intubation-free general anesthesia; Hemodynamics; Respiratory function","NOT_YET_RECRUITING","2026-06-22",{"date":102,"type":103},"2026-06-26","ACTUAL",{"date":105,"type":91},"2026-07-01",{"date":107,"type":91},"2027-04-01",{"name":5,"class":6},1]