[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633384":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":56,"centralContacts":60,"locations":70,"responsibleParty":86,"collaborators":64,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":64,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":64,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":72,"whyStopped":64,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"High-dose anrikefon group","EXPERIMENTAL","Postoperative patient-controlled intravenous analgesia is established with anrikefon 1000 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.",[13],"Drug: High-dose anrikefon",{"label":15,"type":10,"description":16,"interventionNames":17},"Medium-dose anrikefon group","Postoperative patient-controlled intravenous analgesia is established with anrikefon 750 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.",[18],"Drug: Medium-dose anrikefon",{"label":20,"type":10,"description":21,"interventionNames":22},"Low-dose anrikefon group","Postoperative patient-controlled intravenous analgesia is established with anrikefon 500 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.",[23],"Drug: Low-dose anrikefon",{"label":25,"type":26,"description":27,"interventionNames":28},"Morphine group","ACTIVE_COMPARATOR","Postoperative patient-controlled intravenous analgesia is established with morphine 50 mg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml",[29],"Drug: Morphine",[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","High-dose anrikefon","Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (10 μg\u002Fml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.",[9],[37],"High-dose anrikefon-based patient-controlled analgesia",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Medium-dose anrikefon","Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (7.5 μg\u002Fml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.",[15],[43],"Medium-dose anrikefon-based patient-controlled analgesia",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Low-dose anrikefon","Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (5 μg\u002Fml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.",[20],[49],"Low-dose anrikefon-based patient-controlled analgesia",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Morphine","Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises morphine (0.5 mg\u002Fml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.",[25],[55],"Morphine-based patient-controlled analgesia",[57],{"name":58,"affiliation":5,"role":59},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[61,66],{"name":58,"role":62,"phone":63,"phoneExt":64,"email":65},"CONTACT","8610 83572784",null,"wangdongxin@hotmail.com",{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},"Chun-Qing Li, MD","8610 83575138","lichuntsing@163.com",[71],{"facility":5,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":79,"coordinates":80},"Point",[81,82],116.39723,39.9075,{"lat":82,"lon":81},[85],{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},{"type":59,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Dong-Xin Wang","Professor and Chairman, Department of Anaesthesiology","100633384","phase-4-anrikefon-based-patient-controlled-intravenous-analgesia-following-laparoscopic-surgery-100633384",false,"NCT07525986","Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery","Efficacy of Anrikefon-based Patient-controlled Intravenous Analgesia for Pain Management After Laparoscopic Surgery: a Randomized, Double-blind, Active-controlled Pilot Tria","Inclusion Criteria:\n\n1. Aged \\>= 18 years but \\\u003C 75 years;\n2. Scheduled to undergo elective laparoscopic colorectal surgery with an expected duration of \\>=1 hour;\n3. The incisional pain can be covered by the transversus abdominis plane block or rectus sheath block; yet patients still require postoperative patient-controlled intravenous analgesia.\n\nExclusion Criteria:\n\n1. Presence of preoperative cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score \\\u003C 27), or inability to communicate due to language barrier;\n2. Body mass index (BMI) \\> 30 kg\u002Fm² or \\\u003C 18 kg\u002Fm²;\n3. Presence of poorly controlled or untreated comorbidities, including but not limited to the following: hypertension characterized by a resting systolic blood pressure (SBP) \\> 180 mmHg and\u002For diastolic blood pressure (DBP) \\> 110 mmHg, coronary artery disease with unstable angina or myocardial infarction within 6 months, heart failure rated as New York Heart Association classification \\>= III, severe chronic obstructive pulmonary disease (or in a state of acute exacerbation), severe hepatic insufficiency (Child-Pugh grade C), severe renal insufficiency (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73m²), or American Society of Anesthesiologists (ASA) physical status classification \\>= IV;\n4. Continuous use of opioid analgesics for more than 10 days for any reason, or alcohol abuse (average daily intake of pure alcohol \\> 36 g) within 3 months before screening;\n5. Preoperative use of opioid or non-opioid analgesics with the interval between the last administration and randomization shorter than five half-lives of the drug or the duration of drug action (whichever is longer);\n6. Known allergies or contraindications to opiates or other medications that may be used in this study, such as anesthetics, antiemetics, and nonsteroidal anti-inflammatory drugs (NSAIDs);\n7. Anticipated need for postoperative mechanical ventilation；\n8. Other conditions that are considered unsuitable for study participation.","ALL","18 Years","75 Years",{"count":100,"type":101},140,"ESTIMATED","INTERVENTIONAL",[104],"PHASE4","Visceral pain following laparoscopic surgery is frequently underestimated, yet it is associated with a range of adverse outcomes. Effective visceral pain management should constitute an essential component of postoperative analgesic strategies following laparoscopic procedures. However, conventional analgesic agents, including μ-opioid receptor agonists, lack specificity for visceral pain. Anrikefon, a novel selective peripheral κ-opioid receptor agonist, demonstrates unique efficacy in alleviating visceral pain with a favorable safety profile. Preliminary studies showed that a single intravenous dose of anrikefon effectively alleviates postoperative pain after abdominal surgery with a low risk of adverse effects. The investigators hypothesize that an appropriate dosing regimen of anrikefon administered via patient-controlled intravenous analgesia (PCIA) pump, as part of a multimodal analgesic strategy, can specifically target and alleviate visceral pain after laparoscopic surgery, thereby achieving comprehensive postoperative analgesia.",[107,108,109,110],"Laparoscopic Surgery","Visceral Pain, Postoperative","Anrikefon","Patient-controlled Intravenous Analgesia",[112,113,109,114],"Laparoscopic surgery","Visceral pain, Postoperative","Patient-controlled intravenous analgesia","2026-04-22",{"date":117,"type":118},"2026-04-24","ACTUAL",{"date":120,"type":118},"2026-04-14",{"date":122,"type":101},"2027-04",{"name":5,"class":6},1]