Total Knee Arthroplasty
Conditions
Interventions
Pilot group (Group S):Postoperative analgesic regimen Group S: 0.75 mg/kg esketamine + 0.75 µg/kg + sufentanil + 16 mg ondansetron
Control group (Group C):Postoperative analgesic regimen Group C: 1.5ug/kg sufentanil + 16mg ondansetron
Sponsors
Guangdong Hospital of Traditional Chinese Medicine University Town Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age 60-85 years old (including 60 and 85 years old), gender is not limited; (2) 18 kg/m2 <= BMI <= 30 kg/m^2; (2) American Society of Anesthesiologists (ASA) classification I-III; (3) Elderly patients undergoing elective orthopedic total knee arthroplasty under endotracheal general anesthesia; (4) Patients were fully informed about the study and voluntarily signed a written informed consent form before any study-related procedures were initiated.
Exclusion criteria
Exclusion criteria: (1) Known hypersensitivity to the active ingredients or excipients of esketamine hydrochloride, ondansetron, propofol, sufentanil, cis-atracurium; (2) Use of opioids for chronic pain; (3) History of severe cardiovascular disease (e.g., coronary atherosclerotic heart disease, heart failure, and arrhythmias requiring treatment); angina pectoris (unstable angina) due to insufficient blood supply to the coronary vessels of the heart, or myocardial infarction within the last 6 months; (4) Persons whose blood pressure is not satisfactorily controlled (sitting systolic blood pressure >= 160 mmHg at Screening and/or diastolic blood pressure = 100 mmHg at Screening); (5) Patients with a history of hyperthyroidism; (6) Patients with a history of elevated intraocular pressure (e.g., glaucoma) or puncture eye injury; (7) Patients with asthma history; (8) Abnormal liver function, AST and/or ALT>=1.5×ULN, TBIL>=1.5×ULN; (9) Abnormal renal function, BUN>=1.5×ULN, blood creatinine exceeding the upper limit of normal value; (10) NYHK cardiac function grade >=?; (11) Partners who are known to suffer from mental illness and cannot communicate verbally; (12) Patients with MMSE score < 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid consumption; | — |
Countries
China
Contacts
Public ContactFei Ye
Guangzhou University of Chinese Medicine
Outcome results
None listed