[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593697":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":30,"responsibleParty":49,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":30,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":30,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":75,"whyStopped":30,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":30},{"fullName":5,"class":6},"Chengdu Jinjiang Maternity and Child Health Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"N1 Group","EXPERIMENTAL","Patients in this group will receive Nalbuphine at a concentration of 0.20 mg\u002Fml, totaling 30 mg, combined with 10 mg of Metoclopramide for postoperative analgesia. This group aims to evaluate the effects of this specific dosing on anxiety and depression levels following ectopic pregnancy surgery.",[13],"Drug: Nalbuphine 0.20mg\u002Fml(total 30 mg)",{"label":15,"type":10,"description":16,"interventionNames":17},"N2 Group","articipants in this group will be administered Nalbuphine at a concentration of 0.27 mg\u002Fml, totaling 40 mg, along with 10 mg of Metoclopramide for postoperative pain management. The focus will be on assessing the impact of this dosage on the patients' anxiety and depression scores post-surgery.",[18],"Drug: Nalbuphine 0.27mg\u002Fml(total 40 mg)",{"label":20,"type":10,"description":21,"interventionNames":22},"N3 Group","Individuals in this group will receive Nalbuphine at a concentration of 0.33 mg\u002Fml for a total of 50 mg, paired with 10 mg of Metoclopramide for effective postoperative analgesia. This group will help determine the effects of this higher dosage on levels of anxiety and depression after surgery for ectopic pregnancy.",[23],"Drug: Nalbuphine 0.33mg\u002Fml(total 50 mg)",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Nalbuphine 0.20mg\u002Fml(total 30 mg)","In this group, participants will receive an intravenous infusion of Nalbuphine at a concentration of 0.20 mg\u002Fml, which delivers a total of 30 mg over the course of 48 hours. Additionally, 10 mg of Metoclopramide will be administered to manage potential postoperative nausea. This intervention aims to assess the analgesic efficacy and its subsequent effect on psychological outcomes, specifically anxiety and depression, in patients undergoing surgery for ectopic pregnancy.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Nalbuphine 0.27mg\u002Fml(total 40 mg)","Participants assigned to this group will be treated with an intravenous infusion of Nalbuphine at a concentration of 0.27 mg\u002Fml, resulting in a total dosage of 40 mg administered during the 48-hour postoperative period. They will also receive 10 mg of Metoclopramide to mitigate nausea and vomiting. This intervention is designed to evaluate the effectiveness of this dose in pain management and its influence on anxiety and depression levels post-surgery.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Nalbuphine 0.33mg\u002Fml(total 50 mg)","In this group, subjects will receive Nalbuphine at a concentration of 0.33 mg\u002Fml, totaling 50 mg, delivered through intravenous infusion for 48 hours. Along with this, 10 mg of Metoclopramide will be included to address potential postoperative discomfort. This intervention seeks to explore how this higher concentration impacts pain relief and subsequent psychological effects, specifically targeting anxiety and depression following ectopic pregnancy surgery.",[20],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Bo Liu, MS","CONTACT","+8618502846036","liubojjfy@163.com",{"name":46,"role":42,"phone":47,"phoneExt":30,"email":48},"Fei Jia, MD","+8618581877655","jiafei1980@sina.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Fei Jia","Director of Anesthesiology Department","100593697","nalbuphine-dosing-and-its-impact-on-anxiety-and-depression-in-ectopic-pregnancy-surgery-100593697",false,"NCT07009808","Nalbuphine Dosing and Its Impact on Anxiety and Depression in Ectopic Pregnancy Surgery","Effects of Different Doses of Nalbuphine on Anxiety and Depression in Patients Undergoing Ectopic Pregnancy Surgery: A Prospective, Randomized, Controlled Study","Inclusion Criteria:\n\n1. Confirmed diagnosis of ectopic pregnancy, aged ≥18 years, and with normal psychological status.\n2. Patients planned to undergo single-port laparoscopic surgery under general anesthesia, followed by postoperative patient-controlled intravenous analgesia (PCIA).\n3. Patients classified as ASA I or II.\n4. Able to understand the study process and methods, voluntarily participate, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients using other analgesic methods or multiple analgesic approaches.\n2. Patients with a history of allergies or allergies to anesthetic drugs.\n3. Patients with a history of depression or mental illness.\n4. Patients with other severe organ dysfunction.\n5. Patients unable to operate the intravenous analgesia pump independently.","FEMALE","18 Years",{"count":63,"type":64},165,"ESTIMATED","INTERVENTIONAL",[67],"NA","This prospective, randomized, controlled study aims to evaluate the impact of different doses of nalbuphine on anxiety and depression in patients undergoing surgery for ectopic pregnancy. Ectopic pregnancy, which occurs in approximately 2% of all pregnancies, often requires surgical intervention, leading to potential psychological distress such as anxiety and depression in affected women. Effective postoperative pain management is essential to enhance recovery and reduce emotional disturbances.\n\nThe study will involve 165 eligible patients diagnosed with ectopic pregnancy at Jinjiang District Maternal and Child Health Hospital. Participants will be randomly assigned to three groups, each receiving a different concentration of nalbuphine combined with metoclopramide for postoperative analgesia. The primary outcome will focus on changes in anxiety and depression scores measured on postoperative day three, while secondary outcomes will assess pain levels, the use of patient-controlled analgesia (PCA), the necessity for rescue analgesics, and the occurrence of adverse reactions.\n\nSample size calculations suggest that at least 165 participants are required to achieve adequate statistical power. Data will be analyzed using SPSS 25.0 software, with results expected to provide insights into the effectiveness of nalbuphine in improving postoperative recovery and mental health in women experiencing ectopic pregnancy. The study has received ethical approval and is funded by the Chengdu Medical Research Projects (No. 2023465, 2022548, and 2023304).",[70,71,72,73],"Ectopic Pregnancy","Anxiety","Depression","Nalbuphine",[70,71,72,73],"NOT_YET_RECRUITING","2025-06-06",{"date":78,"type":79},"2025-06-08","ACTUAL",{"date":81,"type":64},"2025-06-20",{"date":83,"type":64},"2025-10-30",{"name":5,"class":6}]