[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658766":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":29,"studyPopulation":29,"armGroups":59,"interventions":72,"overallOfficials":29,"centralContacts":29,"locations":29,"responsibleParty":81,"collaborators":29,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":29,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":29,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":29,"overallStatus":105,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":29},{"fullName":5,"class":6},"RenJi Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence of composite adverse events during sedation","Composite adverse events are defined as the occurrence of hypoxemia and\u002For hypotension. Hypoxemia is defined as SpO₂ \\\u003C 90%, and hypotension is defined as a mean arterial pressure (MAP) ≤ 70 mmHg or a decrease of more than 30% from baseline.","During the sedation period of the prostate biopsy procedure",[14,17,20,23,27,30,33,37,39,41,45,48],{"measure":15,"description":16,"timeFrame":12},"The incidence of hypoxia during the sedation process.","SpO2 \\\u003C 90%",{"measure":18,"description":19,"timeFrame":12},"The incidence of severe hypoxia during the sedation process.","SPO2 is between 75% and 90% for a duration of ≥ 60 seconds, or SPO2 is less than 75%",{"measure":21,"description":22,"timeFrame":12},"The incidence of subclinical respiratory depression during the sedation process.","90% ≤ SpO2 \\\u003C 95%",{"measure":24,"description":25,"timeFrame":26},"The incidence of hypotension during the sedation period .","Hypotension is defined as a mean arterial pressure (MAP) ≤ 70 mmHg or a decrease of more than 30% from baseline.","During the sedation period for prostate biopsy surgery",{"measure":28,"description":29,"timeFrame":12},"Success rate of sedation",null,{"measure":31,"description":32,"timeFrame":12},"Induction Time","The time from the first administration of sedatives (remiamorol or propofol) to when the MOAA\u002FS score reaches ≤1 indicating a sedated state",{"measure":34,"description":35,"timeFrame":36},"Awakening time","The time from the cessation of drug administration to when the MOAA\u002FS score remained at 5 for three consecutive times","During the recovery period of the prostate biopsy procedure",{"measure":38,"description":29,"timeFrame":12},"The incidence rate of injection pain",{"measure":40,"description":29,"timeFrame":12},"The incidence of patient movement during the procedure.",{"measure":42,"description":43,"timeFrame":44},"Operator satisfaction with the conduct of the prostate biopsy procedure","After the prostate puncture procedure, ask about the satisfaction level with the operating doctor. Assess using a Numerical Rating Scale ranging from 0 to 10, where 1 to 3 means \"dissatisfied,\" 4 to 6 means \"satisfied,\" and 7 to 10 means \"very satisfied.\"","During the whole prostate biopsy procedure",{"measure":46,"description":47,"timeFrame":44},"Patient satisfaction","Before the patient leaves the recovery room after fully waking up, ask about the patient's satisfaction level. Assess using a Numerical Rating Scale ranging from 0 to 10, where 1 to 3 means \"dissatisfied,\" 4 to 6 means \"satisfied,\" and 7 to 10 means \"very satisfied.\"",{"measure":49,"description":50,"timeFrame":51},"Visual Analogue Scale (VAS) score 15 minutes after prostate biopsy","Perform a pain assessment using a Visual Analogue Scale (VAS) 15 minutes after the surgery, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain the patient has ever experienced.","15 minutes after prostate biopsy",{"allocation":53,"interventionModel":54,"interventionModelDescription":29,"primaryPurpose":6,"observationalModel":29,"timePerspective":29,"maskingInfo":55},"RANDOMIZED","PARALLEL",{"masking":56,"maskingDescription":29,"whoMasked":57},"SINGLE",[58],"OUTCOMES_ASSESSOR",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"Remimazolam group","EXPERIMENTAL","Administer 0.2mg\u002Fkg of remimazolam for sedation",[65],"Drug: Using remimazolam for sedation during prostate biopsy",{"label":67,"type":68,"description":69,"interventionNames":70},"Propofol group","ACTIVE_COMPARATOR","Administer 1.5mg\u002Fkg of propofol for sedation",[71],"Drug: Administer 1.5mg\u002Fkg of propofol for sedation",[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":29},"DRUG","Using remimazolam for sedation during prostate biopsy","Administer 0.2mg\u002Fkg remimazolam, with the infusion time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA\u002FS score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 5-10ml of 2% lidocaine, and then begins the prostate puncture procedure.",[61],{"type":74,"name":69,"description":79,"armGroupLabels":80,"otherNames":29},"Administer 1.5mg\u002Fkg of propofol, with the injection time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA\u002FS score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 2% lidocaine, and then begins the prostate puncture procedure.",[67],{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Jie Tian","Principal Investigator","100658766","effect-of-remimazolam-on-hypoxemia-andor-hypotension-in-prostate-biopsy-100658766",false,"NCT07854197","Effect of Remimazolam on Hypoxemia and\u002For Hypotension in Prostate Biopsy","Effect of Remimazolam Sedation on Composite Adverse Events in Elderly Patients Undergoing Prostate Biopsy: A Prospective Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* 65 years old ≤ age ≤ 80 years old;\n* undergo sedated transperineal prostate biopsy;\n* 18.5kg\u002Fm2 ≤ BMI\\\u003C30kg\u002Fm2\n* ASA ≤ III;\n* voluntarily participate in the research and sign the informed consent form.\n\nExclusion Criteria:\n\n* expected difficult airway;\n* hypertension (with a systolic blood pressure of ≥ 180 mmHg and\u002For a diastolic blood pressure of ≥ 100 mmHg), or with a systolic blood pressure of ≤ 90 mmHg;\n* baseline SpO2 \\\u003C 93%, or RR \\\u003C 10 b\u002Fm or more than 24 b\u002Fm, or a clear diagnosis of obstructive sleep apnea syndrome (OSAS);\n* diagnosed with heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.);\n* diagnosed with lung diseases (asthma, bronchitis, COPD, pulmonary bullae, pulmonary embolism, pulmonary oedema, etc.);\n* hepatic dysfunction (aspartate aminotransferase and\u002For alanine aminotransferase ≥ 2.5 times the upper limit of normal value, total bilirubin ≥ 1.5 times the upper limit of normal value);\n* renal insufficiency (creatinine level ≥ 1.5 times the upper limit of the normal range);\n* cognitive or mental disorders;\n* history of drug and\u002For alcohol abuse within 2 years before initiating the screening period; average daily alcohol consumption of \\>2 units of alcohol (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol content or 150 mL grapes liquor);\n* allergies or contraindication to benzodiazepines, opioids, propofol;\n* use of benzodiazepines, propofol and opioid drugs within the past three months;\n* participated in other drug clinical trials in the past 3 months;\n* investigator's judgment as an unsuitable participant.","MALE","65 Years","80 Years",{"count":96,"type":97},1146,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study aims to investigate whether remimazolam, a novel benzodiazepine sedative, can reduce the composite incidence of hypotension and hypoxemia during prostate biopsy in elderly patients compared with propofol. This study is a multicenter prospective randomized controlled trial.Participants will be recruited from five centers: Renji Hospital (Shanghai), Sun Yat-sen University Cancer Center, Zhongda Hospital (Nanjing), Shenzhen Hospital of the Cancer Hospital (CAMS), and Liaoning Fangda General Hospital.Baseline data will be collected for all participants, including demographic information, comorbidities, concurrent medication use, and vital signs.A total of 1,146 eligible participants will be randomized in a 1:1 ratio to receive either remimazolam (experimental group) or propofol (control group). Intraoperative hypoxemia and hypotension will be recorded as the primary outcomes. Secondary outcomes will include other sedation-related adverse events and patient satisfaction, which will be evaluated to comprehensively assess the efficacy and safety profile of remimazolam.",[103,104],"Prostate Biopsy","Sedation Complication","NOT_YET_RECRUITING","2026-10-05",{"date":108,"type":109},"2026-10-08","ACTUAL",{"date":108,"type":97},{"date":112,"type":97},"2027-07-01",{"name":5,"class":6}]