Actively Recruiting
Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty
Led by Qianfoshan Hospital · Updated on 2025-12-09
162
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of administering nalbuphine, an opioid analgesic, at different perioperative time points on pain relief and hemodynamic stability in elderly patients undergoing total knee arthroplasty (TKA). TKA is a common surgery to treat advanced osteoarthritis or rheumatoid arthritis, but patients often experience moderate to severe postoperative pain. Maintaining stable blood pressure and adequate brain perfusion during surgery is important to prevent heart and brain injury caused by tourniquet use and controlled hypotension. Participants will receive general anesthesia with a standardized regimen, including dexamethasone, midazolam, sufentanil, etomidate, and atracurium. They will be randomly assigned to one of three groups: one receiving intravenous nalbuphine during anesthesia induction, another receiving nalbuphine after cement implantation, and a control group receiving no nalbuphine. Anesthesia will be maintained with continuous infusions of propofol and remifentanil in all groups. During the study, participants will be assessed for pain using the Visual Analog Scale (VAS) at various times after surgery, including 30 minutes postoperatively, which is the primary outcome. Hemodynamic parameters such as blood pressure and heart rate will be monitored at multiple perioperative time points. The use of rescue pain medication, adverse reactions, surgery duration, and airway device removal time will also be recorded. The study will continue until October 2026, involving elderly participants aged 65 to 90 years.
CONDITIONS
Brief Title
Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily enrolled and provided written informed consent
- Undergoing unilateral total knee arthroplasty under general anesthesia
- Age 65 to 90 years, any gender
- Body mass index (BMI) between 18 and 30 kg/m²
- No psychiatric disorders, normal consciousness, able to communicate
- American Society of Anesthesiologists (ASA) physical status I-III
- No contraindications to study medications
You will not qualify if you...
- Uncontrolled or untreated hypertension with resting blood pressure over 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 exceeding 2 units per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo total knee arthroplasty under general anesthesia. Depending on group assignment, nalbuphine is administered either during anesthesia induction or after cement implantation, or not administered at all. Anesthesia is maintained with continuous intravenous infusion of propofol and remifentanil. The surgical duration and laryngeal mask airway removal time are recorded.
1 visit (in-person)
Duration - 24 hours postoperatively
Participants are monitored for pain and hemodynamic stability after surgery. Pain is assessed at multiple time points up to 24 hours postoperatively using the Visual Analog Scale. The need for rescue analgesic medication and incidence of adverse reactions are also recorded.
Assessments at extubation, 30 minutes, 2, 4, 8, 12, and 24 hours postoperatively
Trial Site Locations
Total: 1 location
1
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
G
Guo Liang, Ph.D
D
Deng Shiyuan, master
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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