[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653403":3},{"organization":4,"outcomesModule":7,"designInfo":98,"detailedDescription":107,"studyPopulation":97,"armGroups":108,"interventions":121,"overallOfficials":97,"centralContacts":129,"locations":135,"responsibleParty":152,"collaborators":97,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":97,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":185,"whyStopped":97,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Beijing Tsinghua Chang Gung Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":97},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of Recovery-15 total score at 48 hours","The validated Chinese QoR-15 contains 15 items scored from 0 to 10. The total score ranges from 0 to 150, with higher scores indicating better recovery. The first valid assessment within the prespecified window is used. If any item cannot be completed, the total score is missing rather than prorated. Participants who die before the assessment window are not assigned a score of zero; mortality is reported separately and addressed in prespecified sensitivity analyses.","48 ± 4 hours after the end of surgery, defined as completion of skin closure (allowable window, 44 to 52 hours)",[14,18,22,25,29,32,36,39,42,45,48,51,55,59,63,67,71,74,77,81,84,88,91,94],{"measure":15,"description":16,"timeFrame":17},"Quality of Recovery-15 total score at 24 hours","Chinese QoR-15 total score, ranging from 0 to 150, with higher scores indicating better recovery. The first valid assessment in the prespecified window is used.","24 ± 2 hours after completion of skin closure (allowable window, 22 to 26 hours)",{"measure":19,"description":20,"timeFrame":21},"Cumulative duration of mean arterial pressure below 65 mmHg","Total number of valid monitored minutes with mean arterial pressure below 65 mmHg.","From initiation of the assigned study hypnotic until completion of skin closure during the index surgery",{"measure":23,"description":24,"timeFrame":21},"Time-weighted average of mean arterial pressure below 65 mmHg","TWA-MAP65 is calculated as the area under the threshold of 65 mmHg divided by valid arterial-pressure monitoring time. It reflects both depth and duration of hypotension and is reported in mmHg. Invasive arterial pressure data are summarized as one-minute medians after prespecified artifact handling.",{"measure":26,"description":27,"timeFrame":28},"Quality of Recovery-15 total score at 72 hours","Chinese QoR-15 total score, ranging from 0 to 150, with higher scores indicating better recovery. Participants discharged before the visit may complete the assessment by a masked telephone interview.","72 ± 6 hours after completion of skin closure (allowable window, 66 to 78 hours)",{"measure":30,"description":31,"timeFrame":21},"Proportion of valid monitoring time with mean arterial pressure below 65 mmHg","Percentage of valid invasive arterial-pressure monitoring time during which mean arterial pressure is below 65 mmHg.",{"measure":33,"description":34,"timeFrame":35},"Lowest intraoperative mean arterial pressure","Lowest valid one-minute median mean arterial pressure, reported in mmHg, after application of prespecified artifact rules.","From initiation of the assigned study hypnotic until completion of skin closure during the index surgery.",{"measure":37,"description":38,"timeFrame":35},"Time to first vasopressor administration","Elapsed time from initiation of the assigned study hypnotic to the first vasopressor dose, reported in minutes. Participants who do not receive a vasopressor are described separately.",{"measure":40,"description":41,"timeFrame":35},"Cumulative dose of vasopressors","Cumulative dose of each vasopressor is reported using the original drug units. A norepinephrine-equivalent dose may also be reported using a conversion rule finalized in the data dictionary before enrollment begins.",{"measure":43,"description":44,"timeFrame":35},"Maximum vasopressor infusion rate","Maximum recorded continuous infusion rate for each vasopressor, using drug-specific units.",{"measure":46,"description":47,"timeFrame":35},"Number of hypotension rescue episodes","Count of prespecified hypotension rescue episodes triggered by mean arterial pressure below 65 mmHg for at least 1 minute or any mean arterial pressure below 55 mmHg, after verification of the arterial waveform and clinical context.",{"measure":49,"description":50,"timeFrame":21},"Number of study-hypnotic dose reductions due to hypotension","Count of dose reductions of the assigned study hypnotic documented as being prompted by hypotension.",{"measure":52,"description":53,"timeFrame":54},"Incidence of acute kidney injury","Acute kidney injury is defined by any KDIGO criterion: serum creatinine increase of at least 0.3 mg\u002FdL (26.5 µmol\u002FL) within 48 hours, increase to at least 1.5 times baseline within the observation window, or urine output below 0.5 mL\u002Fkg\u002Fhour for 6 hours. KDIGO stage is also recorded.","From completion of skin closure through postoperative day 7 or hospital discharge, whichever occurs first.",{"measure":56,"description":57,"timeFrame":58},"Incidence of postoperative infection","Occurrence of surgical-site, intra-abdominal, pulmonary, urinary-tract, catheter-related, or bloodstream infection adjudicated by masked assessors using applicable CDC\u002FNHSN definitions and clinical, imaging, microbiological, and treatment data.","Within 30 days after completion of skin closure",{"measure":60,"description":61,"timeFrame":62},"Incidence of postoperative delirium","Delirium is assessed twice daily. CAM-ICU is administered when the Richmond Agitation-Sedation Scale score is -3 or higher. Any positive CAM-ICU assessment counts as delirium for that day; reasons for inability to assess are recorded.","Postoperative days 1 to 3 or until transfer out of the ICU, whichever occurs first.",{"measure":64,"description":65,"timeFrame":66},"Incidence of postoperative hypoxemia","Oxygen saturation below 90% or arterial oxygen tension below 60 mmHg lasting at least 10 minutes and requiring escalation of oxygen therapy.","Within 7 days after completion of skin closure",{"measure":68,"description":69,"timeFrame":70},"Use of noninvasive ventilation","Any postoperative use of noninvasive positive-pressure ventilation for a clinical indication.","Within 7 days after completion of skin closure.",{"measure":72,"description":73,"timeFrame":66},"Use of high-flow nasal cannula oxygen","Any postoperative use of high-flow nasal cannula oxygen for a clinical indication.",{"measure":75,"description":76,"timeFrame":66},"Incidence of respiratory failure","Postoperative respiratory failure adjudicated according to the prespecified perioperative respiratory outcome definitions.",{"measure":78,"description":79,"timeFrame":80},"Incidence of reintubation","Reinsertion of an endotracheal tube for a clinical indication after the first planned extubation.","Within 7 days after the first planned extubation",{"measure":82,"description":83,"timeFrame":66},"Incidence of pneumonia","Postoperative pneumonia adjudicated using the prespecified clinical, imaging, microbiological, and treatment criteria. Pneumonia may also satisfy the postoperative infection definition and will be reported in both relevant outcome domains without summing event counts into a new composite outcome.",{"measure":85,"description":86,"timeFrame":87},"Incidence of bradycardia","Heart rate below 45 beats per minute for at least 1 minute or bradycardia requiring pharmacologic treatment.","From the first dose of assigned study hypnotic through postoperative day 30",{"measure":89,"description":90,"timeFrame":87},"Incidence of study-drug allergic reactions","Any clinically diagnosed allergic or hypersensitivity reaction attributed as possibly, probably, or definitely related to a study hypnotic.",{"measure":92,"description":93,"timeFrame":87},"Incidence of serious adverse events","Number and proportion of participants with at least one serious adverse event, classified and reported according to the approved protocol and ethics requirements.",{"measure":95,"description":96,"timeFrame":58},"All-cause mortality","Death from any cause.",null,{"allocation":99,"interventionModel":100,"interventionModelDescription":97,"primaryPurpose":101,"observationalModel":97,"timePerspective":97,"maskingInfo":102},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":103,"maskingDescription":97,"whoMasked":104},"DOUBLE",[105,106],"PARTICIPANT","OUTCOMES_ASSESSOR","Cytoreductive surgery for peritoneal surface malignancies often involves extensive peritoneal stripping, multivisceral resection, major fluid shifts, and prolonged anesthesia. Some patients also receive HIPEC. Propofol may cause vasodilation and cardiovascular depression, whereas remimazolam may provide greater hemodynamic stability. Whether this difference translates into clinically meaningful improvement in overall postoperative recovery remains uncertain.\n\nAfter written informed consent and completion of baseline assessments, eligible participants will be randomized 1:1 using variable block sizes of 4, 6, or 8, stratified by whether HIPEC is planned. Allocation will be obtained from a permission-controlled electronic randomization system after eligibility is reconfirmed in the operating room and immediately before the first assigned study hypnotic. Participants, postoperative QoR-15 assessors, complication adjudicators, and the primary statistician will remain masked. Anesthesia clinicians cannot be masked because they must titrate the assigned drug.\n\nBoth groups will receive bispectral index-guided total intravenous anesthesia with a target BIS of 40 to 60 and standardized principles for analgesia, hemodynamic rescue, temperature management, neuromuscular monitoring, extubation, and intensive care. Surgery end is defined as completion of skin closure, and all postoperative assessment windows are anchored to that time.\n\nThe primary outcome is the Chinese QoR-15 total score 48 ± 4 hours after surgery. The primary analysis will use analysis of covariance or an equivalent general linear model with treatment group, baseline QoR-15 score, and planned HIPEC stratum as covariates. The adjusted between-group mean difference, 95% confidence interval, and two-sided P value will be reported. The sample size of 320 provides 90% power to detect a 6-point difference assuming a common standard deviation of 15 and allowing 15% for an unavailable primary outcome or loss to follow-up.",[109,115],{"label":110,"type":111,"description":112,"interventionNames":113},"Remimazolam","EXPERIMENTAL","Participants receive remimazolam for induction and maintenance of general anesthesia. Drug dosing is titrated using a common BIS target of 40 to 60 and the same prespecified perioperative management principles used in the comparator arm.",[114],"Drug: Remimazolam",{"label":116,"type":117,"description":118,"interventionNames":119},"Propofol","ACTIVE_COMPARATOR","Participants receive propofol for induction and maintenance of general anesthesia. Drug dosing is titrated using a common BIS target of 40 to 60 and the same prespecified perioperative management principles used in the experimental arm.",[120],"Drug: Propofol",[122,126],{"type":123,"name":110,"description":124,"armGroupLabels":125,"otherNames":97},"DRUG","Remimazolam is infused intravenously at 6 mg\u002Fkg\u002Fhour for induction. If a Modified Observer's Assessment of Alertness\u002FSedation score of 1 or lower is not reached after 3 minutes, the rate is increased to 12 mg\u002Fkg\u002Fhour. After loss of consciousness, maintenance starts at 1.0 mg\u002Fkg\u002Fhour and is adjusted in steps of 0.2 mg\u002Fkg\u002Fhour at intervals of at least 5 minutes within an allowed range of 0.5 to 2.0 mg\u002Fkg\u002Fhour to maintain BIS 40 to 60. Infusion stops at completion of skin closure. Dosing weight is actual body weight for BMI below 30 kg\u002Fm² and adjusted body weight for BMI of 30 kg\u002Fm² or higher. Flumazenil is not used routinely and is reserved for clinically indicated rescue.",[110],{"type":123,"name":116,"description":127,"armGroupLabels":128,"otherNames":97},"Propofol 1.5 to 2.5 mg\u002Fkg is administered intravenously over 60 to 90 seconds for induction. After loss of consciousness, maintenance starts at 6 mg\u002Fkg\u002Fhour and is adjusted in steps of 1 mg\u002Fkg\u002Fhour at intervals of at least 5 minutes. The usual range is 4 to 10 mg\u002Fkg\u002Fhour and the allowed range is 3 to 12 mg\u002Fkg\u002Fhour to maintain BIS 40 to 60. Infusion stops at completion of skin closure. Dosing weight is actual body weight for BMI below 30 kg\u002Fm² and adjusted body weight for BMI of 30 kg\u002Fm² or higher.",[116],[130],{"name":131,"role":132,"phone":133,"phoneExt":97,"email":134},"Yi Duan, MD","CONTACT","+86-13810385311","dya01610@btch.edu.cn",[136],{"facility":137,"status":97,"city":138,"state":139,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":148,"contacts":149},"Beijing Tsinghua Changgung Hospital","Beijing","Beijing Municipality","102218","China","CN",{"type":144,"coordinates":145},"Point",[146,147],116.39723,39.9075,{"lat":147,"lon":146},[150,151],{"name":131,"role":132,"phone":133,"phoneExt":97,"email":134},{"name":97,"role":132,"phone":97,"phoneExt":97,"email":134},{"type":153,"investigatorFullName":154,"investigatorTitle":155,"investigatorAffiliation":5,"oldNameTitle":97,"oldOrganization":97},"PRINCIPAL_INVESTIGATOR","Duanyi","Senior Anesthesiologist","100653403","remimazolam-versus-propofol-for-early-recovery-after-cytoreductive-surgery-100653403",false,"NCT07785557","Remimazolam Versus Propofol for Early Recovery After Cytoreductive Surgery","Effect of Remimazolam Versus Propofol on Early Postoperative Quality of Recovery in Patients Undergoing Cytoreductive Surgery for Peritoneal Surface Malignancies: A Randomized Controlled Trial","REPAIR","Inclusion Criteria\n\n1.Age 18 to 75 years. 2.American Society of Anesthesiologists physical status class II or III. 3.Pathologically confirmed primary peritoneal surface malignancy or peritoneal metastasis from colorectal, gastric, ovarian, or appendiceal malignancy.\n\n4.Scheduled for elective cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy under general anesthesia.\n\n5.Expected surgical duration of at least 2 hours and planned postoperative admission to the intensive care unit.\n\n6.Able to understand and independently complete the Chinese Quality of Recovery-15 questionnaire.\n\n7.Willing to participate and able to provide written informed consent. Exclusion Criteria\n\n1. Emergency surgery.\n2. Uncontrolled bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 14 days before surgery, or temperature of 38.0 °C or higher at post-consent eligibility confirmation with corresponding clinical, imaging, microbiological, or laboratory evidence. Perioperative antimicrobial prophylaxis is not an exclusion.\n3. Child-Pugh class C, total bilirubin greater than 3 times the upper limit of normal, or alanine or aspartate aminotransferase greater than 5 times the upper limit of normal.\n4. Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² or maintenance renal replacement therapy.\n5. Known allergy to remimazolam, benzodiazepines, propofol, or their excipients, or a contraindication to either study drug.\n6. Continuous or near-daily opioid use for at least 90 days before surgery, or benzodiazepine or Z-drug use on at least 5 days per week for at least 4 weeks.\n7. Severe cognitive, psychiatric, hearing, speech, or language impairment that prevents understanding and independent completion of the QoR-15 after standardized explanation.\n8. Pregnancy or breastfeeding.\n9. A preoperative plan for continuous epidural analgesia or another continuous regional analgesic technique that is incompatible with the study's standardized intravenous analgesia pathway.\n10. A specific clinical condition that, in the investigator's judgment, would make participation pose an unacceptable risk.","ALL","18 Years","75 Years",{"count":168,"type":169},320,"ESTIMATED","INTERVENTIONAL",[172],"NA","The REPAIR Trial is a single-center, prospective, randomized, parallel-group superiority trial enrolling 320 adults scheduled for elective cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC). Participants will be assigned 1:1 to bispectral index-guided remimazolam- or propofol-based general anesthesia under standardized perioperative care. The primary objective is to determine whether remimazolam improves patient-reported recovery 48 ± 4 hours after surgery, measured by the Chinese 15-item Quality of Recovery score (QoR-15; range, 0 to 150; higher scores indicate better recovery). The investigators hypothesize that remimazolam will produce a higher 48-hour QoR-15 score than propofol. Secondary outcomes will characterize recovery at 24 and 72 hours, intraoperative hypotension burden and vasopressor use, acute kidney injury, infection, delirium, respiratory complications, other safety events, and 30-day mortality.",[175,176],"Peritoneal Neoplasms","Postoperative Recovery",[178,179,110,116,180,181,182,183,184],"Cytoreductive surgery","Hyperthermic intraperitoneal chemotherapy","Quality of Recovery-15","Postoperative quality of recovery","Intraoperative hypotension","Total intravenous anesthesia","Peritoneal surface malignancy","NOT_YET_RECRUITING","2026-08-21",{"date":188,"type":189},"2026-08-25","ACTUAL",{"date":191,"type":169},"2026-08",{"date":193,"type":169},"2028-05",{"name":5,"class":6},1]