[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620761":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":53,"id":58,"slug":11,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixed-rate basal infusion mode group","ACTIVE_COMPARATOR",null,[13],"Procedure: Fixed-rate basal infusion mode",{"label":15,"type":16,"description":11,"interventionNames":17},"Variable-rate feedback infusion mode group","EXPERIMENTAL",[18],"Procedure: Variable-rate feedback infusion mode",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Fixed-rate basal infusion mode","All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL\u002Fh.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Variable-rate feedback infusion mode","All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In variable-rate feedback infusion mode group, a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL\u002Fh, which increased to 2.5 mL\u002Fh, was used whenever the demand dose was administered within lock out interval. The background infusion rate automatically decreased by 0.5 mL\u002Fh when the bolus button was not pressed for 1 hour. The background infusion rate was limited to a maximum of 12.0 mL\u002Fh and a minimum of 1 mL\u002Fh. The specific variable-rate feedback infusion mode setting was based on previous research, and the opinions of manufacturers and researchers to ensure patient safety and to provide effective analgesia.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Fang Luo","CONTACT","13611326978","13611326978@163.com",[36],{"facility":37,"status":38,"city":39,"state":11,"zip":11,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Beijing Tiantan Hospital, Beijing, Beijing 100070","RECRUITING","Beijing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":51,"investigatorFullName":31,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Director, Department of Pain Management, Principal Investigator, Clinical Professor",[54,56],{"name":55,"class":6},"The Second Affiliated Hospital of Hainan Medical University",{"name":57,"class":6},"Youjiang Medical College for Nationalities","100620761",false,"NCT07361822","Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery","Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)","Inclusion Criteria:\n\n* aged between 18 to 65 years;\n* American Society of Anesthesiologists physical status Ⅰ - Ⅲ;\n* Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracic, abdominal, spinal, orthopaedic, and cranial procedures performed using either minimally invasive or open approaches.\n\nExclusion Criteria:\n\n* Allergy to PCA medications;\n* Presence of chronic pain syndromes;\n* Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.","ALL","18 Years","65 Years",{"count":68,"type":69},1170,"ESTIMATED","INTERVENTIONAL",[72],"NA","Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.",[75,76,77,78],"Surgery","Pain Management","Opioid Consumption","Patient-controlled Analgesia","2026-06-11",{"date":81,"type":82},"2026-06-12","ACTUAL",{"date":84,"type":82},"2025-12-30",{"date":86,"type":69},"2027-12-30",{"name":5,"class":6},1]