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
Qianfoshan Hospital
162 participants
Oct 28, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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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Interventions
A single intravenous injection of Nalbuphine Hydrochloride Injection (dose specified, e.g., 0.2 mg/kg) 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.
After intraoperative prosthesis placement, a single intravenous injection of nalbuphine hydrochloride injection (0.2 mg/kg), 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.
Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.
Locations(1)
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NCT07271849