[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618318":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":30,"id":60,"slug":30,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":30,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":30,"overallStatus":77,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"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,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","不限","300000","China",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},[57],{"name":39,"role":40,"phone":30,"phoneExt":30,"email":30},{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":69,"type":70},114,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76],"Gastrectomy","NOT_YET_RECRUITING","2025-12-29",{"date":80,"type":81},"2026-01-09","ACTUAL",{"date":83,"type":70},"2025-12-22",{"date":85,"type":70},"2026-06-30",{"name":5,"class":6},1]