Nalbuphine Timing Effects on Hemodynamics and Analgesia in Elderly Patients
NCT ID: NCT07271849
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
162 participants
INTERVENTIONAL
2025-10-28
2026-10-31
Brief Summary
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Detailed Description
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During TKA, periarticular tissue dissection and osteotomy cause bleeding and traumatic inflammation. Techniques such as tourniquet application and controlled hypotension are commonly employed. However, tourniquet-induced ischemia-reperfusion injury and inappropriate controlled hypotension can result in cardiac and cerebral injury for participants. Therefore, maintaining hemodynamic stability, ensuring adequate cerebral perfusion, and achieving controlled blood pressure throughout the perioperative period are critical factors for participant prognosis .
Opioids remain the conventional medication for perioperative pain relief. While effective for analgesia, they are associated with adverse effects such as respiratory depression, postoperative nausea and vomiting (PONV), and pruritus. Nalbuphine, an opioid acting as a full κ-receptor agonist and partial μ-receptor antagonist, is considered to provide analgesic efficacy equivalent to morphine and is widely used for managing moderate to severe postoperative pain . Studies indicate that nalbuphine offers superior hemodynamic stability and analgesic effects compared to morphine across various surgical procedures. It not only alleviates postoperative pain but also demonstrates a lower incidence of PONV. Its analgesic and sedative properties are also considered safe for use in pediatric populations . Nevertheless, conclusive evidence regarding the analgesic and hemodynamic effects of nalbuphine in elderly participants undergoing knee arthroplasty during the perioperative period remains lacking.
Therefore, this study aims to investigate the impact of administering equivalent doses of nalbuphine at different perioperative time points on analgesia and hemodynamics in elderly participants undergoing total knee arthroplasty.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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)
Nalbuphine Hydrochloride injection was administered during anesthesia induction.
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.
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).
Nalbuphine Hydrochloride injection was administered after cement implantation.
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.
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.
Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.
Interventions
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Nalbuphine Hydrochloride injection was administered during anesthesia induction.
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.
Nalbuphine Hydrochloride injection was administered after cement implantation.
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.
Standard general anesthesia regimen ( nalbuphine was not administered throughout the entire anesthesia process.)
Conventional induction and anesthesia was maintained were performed, with no intravenous nalbuphine administered for analgesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
65 Years
90 Years
ALL
No
Sponsors
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Qianfoshan Hospital
OTHER
Responsible Party
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Liang Guo
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Principal Investigators
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Guo Liang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Qianfoshan Hospital
Locations
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Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University,
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-KY-2025(207)
Identifier Type: -
Identifier Source: org_study_id
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