[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653504":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":11,"studyPopulation":11,"armGroups":93,"interventions":111,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":129,"collaborators":11,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":11,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":11,"enrollmentInfo":141,"targetDuration":11,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":155,"whyStopped":11,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":11},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality",null,"From postoperative day 1 through postoperative day 30",[14,17,20,22,24,26,28,30,33,36,38,40,42,44,46,49,52,54,56,58,60,63,66,69,72,75,77,79,82],{"measure":15,"description":11,"timeFrame":16},"Incidence of Postoperative Delirium","From postoperative day 1 through postoperative day 7",{"measure":18,"description":11,"timeFrame":19},"Incidence of Cognitive Decline","At postoperative day 7 and postoperative day 30",{"measure":21,"description":11,"timeFrame":12},"Incidence of Stroke",{"measure":23,"description":11,"timeFrame":12},"Incidence of Cardiac Complications",{"measure":25,"description":11,"timeFrame":12},"Incidence of Respiratory Failure",{"measure":27,"description":11,"timeFrame":16},"Incidence of Severe Acute Kidney Injury",{"measure":29,"description":11,"timeFrame":12},"Incidence of Infectious Complications",{"measure":31,"description":11,"timeFrame":32},"All-Cause Mortality","Within 30 days after surgery",{"measure":34,"description":11,"timeFrame":35},"Incidence of Intraoperative Hypotension","From the start of maintenance anesthesia until completion of surgery",{"measure":37,"description":11,"timeFrame":35},"Time-Weighted Average Below 0.80 × T0 Mean Arterial Pressure",{"measure":39,"description":11,"timeFrame":35},"Incidence of Intraoperative Hypertension",{"measure":41,"description":11,"timeFrame":35},"Incidence of Intraoperative Bradycardia",{"measure":43,"description":11,"timeFrame":35},"Incidence of Intraoperative Tachycardia",{"measure":45,"description":11,"timeFrame":35},"Time-Weighted Mean of the MAP\u002FHR Ratio",{"measure":47,"description":11,"timeFrame":48},"Incidence of Major Hemodynamic Rescue Interventions","From induction of anesthesia until completion of surgery",{"measure":50,"description":11,"timeFrame":51},"Incidence of Acute Kidney Injury of Any Stage","Within 7 days after surgery",{"measure":53,"description":11,"timeFrame":32},"Incidence of New-Onset Atrial Fibrillation",{"measure":55,"description":11,"timeFrame":32},"Incidence of Postoperative Pulmonary Complications",{"measure":57,"description":11,"timeFrame":32},"Incidence of Unplanned Reoperation or Reintervention",{"measure":59,"description":11,"timeFrame":32},"Incidence of Unplanned Hospital Readmission",{"measure":61,"description":11,"timeFrame":62},"Duration of Mechanical Ventilation","At extubation, approximately 12 hours after surgery",{"measure":64,"description":11,"timeFrame":65},"Intensive Care Unit Length of Stay","At ICU discharge, an average of 3 days",{"measure":67,"description":11,"timeFrame":68},"Postoperative Hospital Length of Stay","At hospital discharge, an average of 7 days",{"measure":70,"description":11,"timeFrame":71},"Incidence of Prespecified Anesthetic-Related Safety Events","Through hospital discharge, approximately 7 days after surgery",{"measure":73,"description":11,"timeFrame":74},"Change in Plasma Phosphorylated Tau 217 Concentration","From the preoperative baseline through postoperative day 3",{"measure":76,"description":11,"timeFrame":74},"Change in Plasma Neurofilament Light Chain Concentration",{"measure":78,"description":11,"timeFrame":74},"Change in Plasma Glial Fibrillary Acidic Protein Concentration",{"measure":80,"description":11,"timeFrame":81},"Cumulative Incidence of the Long-Term Composite Clinical Outcome","At 6 and 12 months after surgery",{"measure":83,"description":84,"timeFrame":81},"Telephone Montreal Cognitive Assessment Score","Cognitive function will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA). Scores range from 0 to 22, with higher scores indicating better cognitive function.",{"allocation":86,"interventionModel":87,"interventionModelDescription":11,"primaryPurpose":88,"observationalModel":11,"timePerspective":11,"maskingInfo":89},"RANDOMIZED","FACTORIAL","PREVENTION",{"masking":90,"maskingDescription":11,"whoMasked":91},"SINGLE",[92],"OUTCOMES_ASSESSOR",[94,100,104,108],{"label":95,"type":96,"description":11,"interventionNames":97},"Targeted BP Management + Remimazolam","EXPERIMENTAL",[98,99],"Other: Targeted Blood Pressure Management","Drug: Remimazolam",{"label":101,"type":96,"description":11,"interventionNames":102},"Targeted BP Management + Propofol",[98,103],"Drug: Propofol",{"label":105,"type":96,"description":11,"interventionNames":106},"Liberal BP Management + Remimazolam",[107,99],"Other: Liberal Blood Pressure Management",{"label":109,"type":96,"description":11,"interventionNames":110},"Liberal BP Management + Propofol",[107,103],[112,116,120,125],{"type":6,"name":113,"description":114,"armGroupLabels":115,"otherNames":11},"Targeted Blood Pressure Management","Mean arterial pressure (MAP) will be maintained at 65 mm Hg or higher from induction of anesthesia until completion of surgery. A confirmed MAP below 65 mm Hg will prompt verification of the arterial pressure measurement and treatment directed at the presumed clinical cause. Treatment may include fluids, blood products, vasopressors, inotropes, heart-rate or rhythm management, cardiac repositioning, temporary pacing, or mechanical circulatory support when clinically indicated.",[101,95],{"type":6,"name":117,"description":118,"armGroupLabels":119,"otherNames":11},"Liberal Blood Pressure Management","No trial-mandated mean arterial pressure target or study-defined treatment threshold will be imposed. Blood pressure will be managed at the discretion of the attending anesthesiologist according to usual clinical practice, the participant's clinical condition, and surgical conditions. Rescue treatment will be unrestricted when required for participant safety.",[109,105],{"type":121,"name":122,"description":123,"armGroupLabels":124,"otherNames":11},"DRUG","Remimazolam","Remimazolam will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg\u002Fkg\u002Fhour and may be titrated within 0.5-1.5 mg\u002Fkg\u002Fhour according to clinical requirements. The infusion will be discontinued at completion of skin closure.",[105,95],{"type":121,"name":126,"description":127,"armGroupLabels":128,"otherNames":11},"Propofol","Propofol will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg\u002Fkg\u002Fhour and may be titrated within 0.5-1.5 mg\u002Fkg\u002Fhour according to clinical requirements. The infusion will be discontinued at completion of skin closure.",[109,101],{"type":130,"investigatorFullName":131,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Kexin Liu","100653504","intraoperative-targeted-versus-liberal-blood-pressure-management-in-patients-undergoing-off-pump-coronary-artery-bypass-grafting-100653504",false,"NCT07787364","Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting","Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: a Study Protocol for a Prospective, Single-centre, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Scheduled for elective, isolated, primary OPCAB under general anaesthesia;\n3. Agree to complete the baseline assessments and postoperative follow-up required by the study protocol.\n\nExclusion Criteria:\n\n1. Known allergy to remimazolam, benzodiazepines, propofol, etomidate, sufentanil, cisatracurium;\n2. Pregnancy or breastfeeding;\n3. Life expectancy \\\u003C30 days because of a noncardiac condition;\n4. Severe cognitive, language, hearing, visual, or communication impairment precluding completion of the required CAM\u002FCAM-ICU or MoCA assessments;\n5. Preoperative AKI within 7 days before surgery, defined by any Kidney Disease: Improving Global Outcomes (KDIGO) criterion: an increase in serum creatinine of ≥0.3 mg∙dL-1 (≥26.5 µmol∙L-1) within 48 hours; an increase to ≥1.5 times a known or presumed baseline value within 7 days; or urine output \\\u003C0.5 mL∙kg-1∙hour-1 for at least 6 hours;\n6. Maintenance hemodialysis or peritoneal dialysis;\n7. Delirium at the preoperative baseline assessment;\n8. Concurrent participation in another interventional clinical trial that could interfere with the study interventions or outcome assessment;\n9. Other condition considered by the investigator to make participation inappropriate.","ALL","18 Years",{"count":142,"type":143},416,"ESTIMATED","INTERVENTIONAL",[146],"NA","The goal of this clinical trial is to learn whether two approaches to anesthesia and blood pressure management can improve care for adults having off-pump coronary artery bypass grafting (OPCAB). OPCAB is a type of heart bypass surgery performed without routinely using a heart-lung machine.\n\nThe main questions this study aims to answer are:\n\n* Does keeping mean arterial pressure (MAP), a measure of average blood pressure, at 65 mm Hg or higher during surgery lower the chance of major complications or death within 30 days after surgery compared with usual clinician-directed blood pressure management?\n* Does remimazolam provide more stable blood pressure and heart rate than propofol when used to maintain general anesthesia during surgery?\n\nThe researchers expect that targeted blood pressure management may lower the chance of major postoperative complications. They also expect that remimazolam may provide more stable blood pressure and heart rate than propofol.\n\nResearchers plan to enroll 416 adults having elective OPCAB surgery. Participants will be randomly assigned to one of four groups. Each group will receive one of two blood pressure strategies and one of two medicines for maintaining general anesthesia.\n\nParticipants will:\n\n* Receive either targeted blood pressure management or usual clinician-directed blood pressure management during surgery.\n* Receive either remimazolam or propofol to maintain general anesthesia after the same standard anesthesia induction.\n* Have routine monitoring during surgery and assessments during recovery after surgery.\n* Complete follow-up assessments after surgery, including assessments of complications, recovery, and longer-term health. Some participants will also provide blood samples for a biomarker substudy.\n\nThe study will also explore whether the effect of the blood pressure strategy differs depending on which anesthetic medicine is used.",[149,150],"Coronary Artery Disease","Postoperative Complications",[152,153,154,122,126,150],"Off-Pump Coronary Artery Bypass Grafting","Blood Pressure Management","Mean Arterial Pressure","NOT_YET_RECRUITING","2026-08-22",{"date":158,"type":159},"2026-08-26","ACTUAL",{"date":161,"type":143},"2026-10-08",{"date":163,"type":143},"2028-03-31",{"name":5,"class":6}]