Perioperative anxiety in patients undergoing primary unilateral total hip arthroplasty.
Conditions
Interventions
Vitamin B6 group:Oral vitamin B6
Placebo group:placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Scheduled to undergo elective primary unilateral total hip arthroplasty (THA); 3. American Society of Anesthesiologists (ASA) physical status classification I–III; 4. The anticipated date of surgery is 30 +/- 5 days after enrollment, allowing sufficient time to complete the preoperative intervention; 5. Able to understand the study objectives and procedures, willing to participate voluntarily, and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to vitamin B6 or any excipient in the study formulation; 2. Moderate-to-severe hepatic or renal impairment, such as Child–Pugh class C liver disease or an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²; 3. A confirmed diagnosis of severe peripheral neuropathy or a central nervous system disorder, such as epilepsy or Parkinson’s disease; or, in the absence of a confirmed diagnosis, symptoms suggestive of neurological dysfunction, including limb numbness, tingling, burning sensations, glove-and-stocking sensory abnormalities, gait instability, a sensation of walking on cotton, or impaired fine motor function; 4. Regular use within the previous 3 months of antidepressants, anxiolytics, antiepileptic drugs, or other medications that substantially affect the GABAergic system, where temporary discontinuation or dose adjustment is not feasible; 5. A clear medical indication requiring long-term or continuous use of vitamin B6 or vitamin B6-containing medications or nutritional supplements that cannot be discontinued or replaced during the study period; 6. A previous diagnosis of a psychotic disorder or the presence of significant cognitive impairment that may interfere with study participation or questionnaire assessment; 7. Pregnant or breastfeeding women; 8. Expected inability to adhere to the prescribed medication regimen or complete the required follow-up during the study period, such as due to serious anticipated adherence problems; 9. Any other condition that, in the investigator’s clinical judgment, makes the individual unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| State anxiety score at 48 hours after surgery;State anxiety score at 24 hours after surgery;State anxiety score within 24 hours before surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kinesiophobia score;Incidence of postoperative nausea and vomiting within 48 hours;Harris Hip Score (HHS);Cumulative opioid consumption within 48 hours after surgery;Postoperative pain intensity;Postoperative sleep quality score; | — |
Countries
China
Contacts
Public ContactZhou Zongke
West China Hospital of Sichuan University
Outcome results
None listed