[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618318":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":30,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":30,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.",[13],"Drug: Placebo Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Anruikfen Intravenous Bolus Injection Group","EXPERIMENTAL","Anruikefen 1 μg\u002Fkg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.",[19],"Drug: Anruikefen (Intravenous Bolus)",{"label":21,"type":16,"description":22,"interventionNames":23},"Anruikefen Intravenous Infusion Group","Anruikefen 1.5 μg\u002Fkg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.",[24],"Drug: Anruikefen (Intravenous Infusion)",[26,31,34],{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"DRUG","Anruikefen (Intravenous Bolus)",[15],null,{"type":27,"name":32,"description":22,"armGroupLabels":33,"otherNames":30},"Anruikefen (Intravenous Infusion)",[21],{"type":27,"name":9,"description":35,"armGroupLabels":36,"otherNames":30},"Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.",[9],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Bin Ke","CONTACT","022-23340123-1061","binke@tmu.edu.cn",[44],{"facility":45,"status":30,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","不限","300000","China","CN",{"type":52,"coordinates":53},"Point",[54,55],117.17667,39.14222,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":30,"phoneExt":30,"email":30},{"type":60,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100618318","phase-2-efficacy-and-safety-of-anrikefon-injection-for-the-treatment-of-postoperative-pain-in-patients-undergoing-totally-laparoscopic-radical-distal-gastrectomy-100618318",false,"NCT07330063","Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy","Inclusion Criteria:\n\n* Aged between 18 and 70 years old (inclusive).\n* American Society of Anesthesiologists (ASA) physical status classification Class I-III.\n* Body Mass Index (BMI) ranging from 18 kg\u002Fm² to 30 kg\u002Fm² (inclusive).\n* Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration \\\u003C 5 hours.\n* Surgical incision length \\\u003C 8 cm.\n* Voluntarily agree to participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery or suffering from trauma.\n* Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.\n* Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).\n* Patients with a history of prior abdominal surgery.\n* Patients expected to require prolonged endotracheal intubation after surgery.","ALL","18 Years","70 Years",{"count":71,"type":72},114,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.\n\nTherefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.",[78],"Gastrectomy","NOT_YET_RECRUITING","2025-12-29",{"date":82,"type":83},"2026-01-09","ACTUAL",{"date":85,"type":72},"2025-12-22",{"date":87,"type":72},"2026-06-30",{"name":5,"class":6},1]