[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556857":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":44,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":44,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":92,"whyStopped":44,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oliceridine","EXPERIMENTAL","In the experimental group, the acute pain after surgery will be treated with Oliceridine, Dexmedetomidine, Ondansetron via patient controlled analgesia for 48 hours. Oliceridine 0.4-0.6mg\u002Fkg, Dexmedetomidine 2ug\u002Fkg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml\u002Fh, bolus for 2ml\u002F time, locked for 15min, maximum dose for 12ml\u002Fh.",[13],"Drug: Oliceridine Injection [Olinvyk]",{"label":15,"type":16,"description":17,"interventionNames":18},"Sufentanil","ACTIVE_COMPARATOR","In the control group, the acute pain after surgery will be treated with Sufentanil, Dexmedetomidine, and Ondansetron via patient controlled analgesia for 48 hours. Sufentanil 2ug\u002Fkg , Dexmedetomidine 2ug\u002Fkg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml\u002Fh, bolus for 2ml\u002F time, locked for 15min, maximum dose for 12ml\u002Fh.",[19],"Drug: Sufentanil Citrate",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oliceridine Injection [Olinvyk]","Oliceridine fumarate injection, specifications: 1mg\u002F1mL, 2mg\u002F2 mL, 10mg\u002F10 mL; Stored in the dark, 15-30 ℃, not frozen; Jiangsu Nhwa pharmaceutical co., LTD. Production.\n\nDexmedetomidine, specifications: 200ug\u002F2ml; Ondansetron, specifications: 8mg\u002F4ml.",[9],[27,28],"Oliceridine fumarate injection","H20233508",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sufentanil Citrate","Sufentanil Citrate injection, specification: 50 ug\u002Fml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD.\n\nDexmedetomidine, specifications: 200ug\u002F2ml; Ondansetron, specifications: 8mg\u002F4ml.",[15],[34],"sufentanil injection",[36],{"name":37,"affiliation":5,"role":38},"e wang, doctor","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"shinan deng, master","CONTACT","18890362081",null,"2667806135@qq.com",{"name":37,"role":42,"phone":47,"phoneExt":44,"email":48},"18874889950","ewang324@163.com",[50],{"facility":5,"status":44,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Changsha","Hunan","410000","China","CN",{"type":57,"coordinates":58},"Point",[59,60],112.97087,28.19874,{"lat":60,"lon":59},[63],{"name":37,"role":42,"phone":47,"phoneExt":44,"email":48},{"type":65,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[67],{"name":68,"class":6},"Wu Jieping Medical Foundation","100556857","phase-4-the-efficacy-and-safety-of-oliceridine-fumarate-injection-for-acute-pain-after-abdominal-surgery-100556857",false,"NCT06530563","the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery","the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study","Inclusion Criteria:\n\n1.Preoperative inclusion criteria\n\n1. aged ≥18 years and ≤75 years at screening;\n2. Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours.\n3. able to understand and comply with research procedures and requirements, and can provide a written informed consent.\n\n2.postoperative inclusion criteria:\n\n1. patients who required open or laparoscopic surgery;\n2. According to the investigator's judgment, the patient had recovered sufficiently from the intraoperative anesthesia protocol to accurately complete the protocol-specified questionnaire;\n\nExclusion Criteria:\n\n1.preoperative exclusion criteria:\n\n1. ASA grade \\>III\n2. existing other acute or chronic pain conditions;\n3. body mass index (BMI) \\\u003C 18 or \\> 30 kg\u002Fm2;\n4. with sleep apnea syndrome; 5 ) long-term opioid treatment, defined as receiving more than 15mg morphine equivalent units per day on more than 3 days per week for a period of more than 1 month in the 12 months prior to surgery;\n\n6\\) suffering from mental or nervous system diseases (such as epilepsy, depression, schizophrenia, etc.), chronic obstructive pulmonary disease or pulmonary heart disease, heart failure, severe arrhythmia, etc; 7) with severe liver and kidney dysfunction; 8) Other conditions considered by the investigator to be inappropriate for enrollment.\n\nPostoperative exclusion criteria:\n\n1. intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study;\n2. evidence of hemodynamic instability or respiratory insufficiency.","ALL","18 Years","75 Years",{"count":80,"type":81},606,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery. It will also learn about the safety of Oliceridine fumarate injection. The main questions it aims to answer are:\n\n1. Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery?\n2. Does Oliceridine fumarate injection lead to less adverse effect?\n\nResearchers will compare Oliceridine fumarate injection to a positive-drug (Sufentanil Citrate) to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery.\n\nParticipants will:\n\n1. Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery\n2. Be followed up every 6 hours until 48 hours after surgery or before discharge",[87,88],"Acute Pain","Opioid Analgesic Adverse Reaction",[9,90,91],"acute pain after surgery","abdominal surgery","NOT_YET_RECRUITING","2025-08-18",{"date":95,"type":96},"2025-08-19","ACTUAL",{"date":98,"type":81},"2025-08",{"date":100,"type":81},"2026-05",{"name":5,"class":6},1]