Actively Recruiting

Phase 4
Age: 65Years - 90Years
All Genders
NCT07271849

Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

Led by Qianfoshan Hospital · Updated on 2025-12-09

162

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients

Who Can Participate

Age: 65Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must voluntarily enroll and provide written informed consent after understanding the trial's purpose
  • Undergoing unilateral total knee arthroplasty with general anesthesia
  • Age between 65 and 90 years, any gender
  • Body mass index between 18 kg/m² and 30 kg/m²
  • No psychiatric disorders, normal consciousness, and able to communicate effectively
  • Classified as ASA physical status I to III
  • No contraindications to study medications
Not Eligible

You will not qualify if you...

  • Uncontrolled or untreated high blood pressure (resting systolic/diastolic >180/100 mmHg)
  • Severe respiratory diseases
  • Abnormal liver or kidney function (ALT/AST >2.5 times normal, bilirubin >1.5 times normal, creatinine >1.5 times normal)
  • History of drug abuse, illicit drug use, or alcohol abuse (daily alcohol intake exceeding 2 units)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,

Jinan, Shandong, China, 250000

Actively Recruiting

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Research Team

G

Guo Liang, Ph.D

CONTACT

D

Deng Shiyuan, master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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