[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613842":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":75,"collaborators":42,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":42,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":59,"whyStopped":42,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group N0","EXPERIMENTAL","Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg\u002Fkg), sufentanil (0.2-0.4 μg\u002Fkg), etomidate (0.15-0.3 mg\u002Fkg), and atracurium (0.3-0.6 mg\u002Fkg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg\u002Fkg) was administered during anesthesia induction. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg\u002Fkg\u002Fh) and remifentanil (0.15-0.3 μg\u002Fkg\u002Fmin)",[13],"Drug: Nalbuphine Hydrochloride injection was administered during anesthesia induction.",{"label":15,"type":10,"description":16,"interventionNames":17},"Group N1","Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg\u002Fkg), sufentanil (0.2-0.4 μg\u002Fkg), etomidate (0.15-0.3 mg\u002Fkg), and atracurium (0.3-0.6 mg\u002Fkg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg\u002Fkg) was administered after cement implantation. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg\u002Fkg\u002Fh) and remifentanil (0.15-0.3 μg\u002Fkg\u002Fmin).",[18],"Drug: Nalbuphine Hydrochloride injection was administered after cement implantation.",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group (Group C)","ACTIVE_COMPARATOR","Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg\u002Fkg), sufentanil (0.2-0.4 μg\u002Fkg), etomidate (0.15-0.3 mg\u002Fkg), and atracurium (0.3-0.6 mg\u002Fkg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted Conventional induction and anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg\u002Fkg\u002Fh) and remifentanil (0.15-0.3 μg\u002Fkg\u002Fmin) were performed, with no intravenous nalbuphine administered for analgesia.",[24],"Other: Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)",[26,33,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Nalbuphine Hydrochloride injection was administered during anesthesia induction.","A single intravenous injection of Nalbuphine Hydrochloride Injection (dose specified, e.g., 0.2 mg\u002Fkg) was administered to the patient during general anesthesia induction. Neither the control group nor intervention group N1 received the drug during this stage.The remainder of the anesthesia protocol was consistent across all three groups.",[9],[32],"Nalbuphine",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Nalbuphine Hydrochloride injection was administered after cement implantation.","After intraoperative prosthesis placement, a single intravenous injection of nalbuphine hydrochloride injection (0.2 mg\u002Fkg), identical to that in Intervention Group N0) was administered. Neither the control group nor Intervention Group N0 received medication at this timing. All other anesthesia management procedures were standardized.",[15],[32],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)","Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.",[20],null,[44],{"name":45,"affiliation":5,"role":46},"Guo Liang, Ph.D","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":42,"email":51},"CONTACT","8617096838266","2330guoliang@163.com",{"name":53,"role":49,"phone":54,"phoneExt":42,"email":55},"Deng Shiyuan, master","8613791127650","13791127650@163.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,","RECRUITING","Jinan","Shandong","250000","China","CN",{"type":66,"coordinates":67},"Point",[68,69],116.99722,36.66833,{"lat":69,"lon":68},[72],{"name":73,"role":49,"phone":74,"phoneExt":42,"email":51},"Liang Guo, Ph.D","86 170 9683 8266",{"type":46,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Liang Guo","The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)","100613842","phase-4-nalbuphine-timing-effects-on-hemodynamics-and-analgesia-in-elderly-patients-100613842",false,"NCT07271849","Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients","Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty","TKA","Inclusion Criteria:\n\n* All study participants voluntarily enrolled in the trial and provided written informed consent after being fully informed of the trial's purpose and significance\n* Participants underwent unilateral total knee arthroplasty under general anesthesia\n* Elderly participants (age ≥ 65 years), regardless of gender\n* Body mass index (BMI) ranging from 18 kg\u002Fm² to 30 kg\u002Fm²\n* Absence of psychiatric disorders, normal consciousness, and ability to communicate effectively\n* American Society of Anesthesiologists (ASA) physical status classification I-III;\n* No contraindications to the study medications\n\nExclusion Criteria:\n\n* Study participants with uncontrolled or untreated hypertension (resting systolic\u002Fdiastolic blood pressure \\>180\u002F100 mmHg)\n* Individuals with severe respiratory diseases\n* Subjects with abnormal liver or renal function (ALT and\u002For AST \\>2.5 times the upper limit of normal, total bilirubin \\>1.5 times the upper limit of normal, serum creatinine \\>1.5 times the upper limit of normal)\n* Individuals with a history of drug abuse, illicit drug use, or alcohol abuse, where alcohol abuse is defined as an average daily alcohol intake exceeding 2 units (1 unit = 360 mL of beer, 45 mL of 40% alcohol by volume spirits, or 150 mL of wine)","ALL","65 Years","90 Years",{"count":90,"type":91},162,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","In total knee arthroplasty (TKA), the use of a tourniquet and controlled hypotension is common. However, ischemia-reperfusion injury induced by the tourniquet and inappropriate controlled hypotension can lead to cardiac and cerebral damage in patients. Consequently, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure during the perioperative period are critical factors influencing patient outcomes. Postoperatively, patients typically experience moderate to severe pain. Severe postoperative pain can result in prolonged hospital stays, increased readmission rates, elevated opioid consumption, and associated nausea and vomiting. Therefore, exploring effective multimodal postoperative pain management strategies is essential. Nalbuphine, an opioid analgesic acting as a full kappa-receptor agonist and a partial mu-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine while potentially offering advantages in maintaining hemodynamic stability. This study aims to investigate the effects of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly patients undergoing knee arthroplasty.",[97,98,99],"Postoperative Pain, Acute","Hemodynamics","Total Knee Arthroplasty (TKA)",[99,101,32,98],"Postoperative Pain","2025-12-06",{"date":104,"type":105},"2025-12-09","ACTUAL",{"date":107,"type":105},"2025-10-28",{"date":109,"type":91},"2026-10-31",{"name":5,"class":6},1]