Knee osteoarthritis
Conditions
Interventions
A(Experimental):Perioperative standard care protocol + oral estazolam 2 mg per dose administered three times daily, initiated one day preoperatively and continued through postoperative day 10.
B (Control):Perioperative standard care protocol + matched oral placebo (2 mg per dose, three times daily), administered following the same schedule as Group A.
C(Non-anxiety Cohort):Perioperative standard care protocol without additional pharmacological intervention.
Sponsors
Xi'an Honghui Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Patients with an American Society of Anesthesiologists(ASA)physical status classification of I-III. (2)Preoperative diagnosis of primary osteoarthritis of the knee,with symptoms predominantly on one side and refractory to conservative treatment. (3) Scheduled for unilateral total knee arthroplasty (TKA); (4) Age =18 years; (5) No history of severe psychiatric disorders or drug dependence. (6) Willingness to provide written informed consent and ability to comply with study protocols.
Exclusion criteria
Exclusion criteria: (1) Patients undergoing bilateral knee replacement, ipsilateral hip and knee replacement, or perioperative surgery at other sites; (2) History of major stress events within 1 month before surgery, including major trauma, significant illness, surgery, or major family crises; (3) Concomitant major diseases such as malignancy, active infection, or other systemic diseases that may confound study outcomes; (4) History of psychiatric disorders, use of psychotropic medications, or severe anxiety; (5) History of dependence on anesthetic agents or substance abuse; (6) Inability to obtain reliable medical history due to communication barriers, language disorders, or non-compliance with data collection; (7) Contraindications to estazolam use, including hypersensitivity to benzodiazepines, glaucoma, or hepatic/renal impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain;Knee Functions;ROM; | — |
Countries
China
Contacts
Public ContactHuang Yuanchi
Xi'an Honghui Hospital
Outcome results
None listed