Effects of Different Administration Timings of Nalbuphine on Hemodynamics and Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
RECRUITING
Jinan
Contact Information
Primary
Guo Liang, Ph.D
2330guoliang@163.com
8617096838266
Backup
Deng Shiyuan, master
13791127650@163.com
8613791127650
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 162
Treatments
Experimental: Group N0
Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg/kg) was administered during anesthesia induction. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min)
Experimental: Group N1
Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted (size selected according to body weight).Intravenous nalbuphine (0.2 mg/kg) was administered after cement implantation. Anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min).
Active_comparator: Control Group (Group C)
Anesthesia Induction: Dexamethasone (10 mg), midazolam (0.01-0.05 mg/kg), sufentanil (0.2-0.4 μg/kg), etomidate (0.15-0.3 mg/kg), and atracurium (0.3-0.6 mg/kg) were administered intravenously. After complete neuromuscular blockade was achieved, a laryngeal mask airway was inserted Conventional induction and anesthesia was maintained by continuous intravenous infusion of propofol (4-12 mg/kg/h) and remifentanil (0.15-0.3 μg/kg/min) were performed, with no intravenous nalbuphine administered for analgesia.
Sponsors
Leads: Qianfoshan Hospital

This content was sourced from clinicaltrials.gov

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