Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-90
SponsorQianfoshan Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • 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.)

Treatment groups

162 Participants
are divided into 3 treatment groups

Sponsors and collaborators