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Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

RecruitingPhase 4Ages 65 Years - 90 YearsAllQianfoshan Hospital
NCT07271849 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * All study participants voluntarily enrolled in the trial and provided written informed consent after being fully informed of the trial's purpose and significance * Participants underwent unilateral total knee arthroplasty under general anesthesia * Elderly participants (age ≥ 65 years), regardless of gender * Body mass index (BMI) ranging from 18 kg/m² to 30 kg/m² * Absence of psychiatric disorders, normal consciousness, and ability to communicate effectively * American Society of Anesthesiologists (ASA) physical status classification I-III; * No contraindications to the study medications Exclusion Criteria: * Study participants with uncontrolled or untreated hypertension (resting systolic/diastolic blood pressure \>180/100 mmHg) * Individuals with severe respiratory diseases * Subjects with abnormal liver or renal function (ALT and/or 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) * 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)
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What it tests

  • Nalbuphine Hydrochloride injection was administered during anesthesia induction.
  • Nalbuphine Hydrochloride injection was administered after cement implantation.
  • Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
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Where

1 site
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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