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The Efficacy and Safety Study of low-dose and short-term Oral Olanzapine in treatment of Patients Undergoing Total Joint Arthroplasty with Significant Perioperative Anxiety

The Efficacy and Safety Study of low-dose and short-term Oral Olanzapine in treatment of Patients Undergoing Total Joint Arthroplasty with Significant Perioperative Anxiety

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081238
Enrollment
Unknown
Registered
2024-02-27
Start date
2023-02-07
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip and knee joint disease

Interventions

The olanzapine group A:Olanzapine 2.5mg qn was taken orally from the day before surgery for a total of 5 days during the perioperative period and stopped on the day of discharge
Control group B:There was no intervention on emotion and sleep during perioperative period
Group C:No intervention, as a prospective observation cohort of patients in Group B (without anxiety)

Sponsors

Department of Orthopaedic surgery, West China Hospital, Sichuan University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 80 years were scheduled to undergo THA/TKA for end-stage hip/knee disease and had abnormal STAI scores before surgery or significant anxiety symptoms.

Exclusion criteria

Exclusion criteria: ? The patient could not swallow pills, be taking antipsychotics, or have a diagnosed psychiatric disorder. ? Preoperative ECG correction of QT interval greater than 450ms, or a history of tip torsion; Patients with past, myocardial infarction or unstable angina, arrhythmia, congestive heart failure, recent postural hypotension or vasovagal syncope, or perioperative hypotension (systolic blood pressure less than 90 mm Hg). ? Patients with olanzapine contraindications, including known drug allergy, Parkinson's disease, or Lewy body dementia.

Design outcomes

Primary

MeasureTime frame
State-Trait Anxiety Inventory-State score;

Secondary

MeasureTime frame
Visual analogue scale-Pain score;Visual analogue scale-Sleep disorder score;Visual analogue scale-Nausea;Incidence of postoperative vomiting;Harris Hip Score and Hospital for Special Surgery Knee Score;Length of stay;Incidence of postoperative complications;Patient satisfaction;Drug-related adverse reactions;

Countries

China

Contacts

Public ContactZongke Zhou

Department of Orthopaedic surgery, West China Hospital, Sichuan University.

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026