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A Comparative Study of Efficacy and Safety of Low-dose and Short-term Oral Olanzapine and Alprazolam in Treatment of Patients with Significant Perioperative Anxiety Undergoing Primary and Revision Total Joint Arthroplasty

A Comparative Study of Efficacy and Safety of Low-dose and Short-term Oral Olanzapine and Alprazolam in Treatment of Patients with Significant Perioperative Anxiety Undergoing Primary and Revision Total Joint Arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083398
Enrollment
Unknown
Registered
2024-04-23
Start date
2024-04-25
Completion date
Unknown
Last updated
2024-04-29

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 group A:Olanzapine 2.5mg qn was taken orally from the day of admission for a total of 5 days during the perioperative period (primary TKA/THA)
The group B:Alprazolam 4mg qn was taken orally from the day of admission for a total of 5 days during the perioperative period (primary TKA/THA)
The group C:There was no intervention on emotion and sleep during perioperative period
The group D:Olanzapine 2.5mg qn was taken orally from the day of admission for a total of 5 days during the perioperative period (revision TKA/THA)
The group E:Alprazolam 4mg qn was taken orally from the day of admission for a total of 5 days during the perioperative period (revision TKA/THA)

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 primary and revision THA/TKA for end-stage hip/knee disease and had abnormal STAI scores before surgery or significant anxiety symptoms.

Exclusion criteria

Exclusion criteria: (i) the patient cannot swallow tablets; (ii) the patient is taking antipsychotic drugs, or has been diagnosed with psychiatric disorders; (iii) the presence of severe cardiovascular disease or past history: preoperative electrocardiogram-corrected QT interval greater than 450 ms, or a history of tip-twisting; previous, myocardial infarction or unstable angina pectoris, cardiac arrhythmia, congestive heart failure, recent postural hypotension or vasovagal syncope, or perioperative Patients with hypotension (systolic blood pressure less than 90 mmHg); ? Severe hepatic or renal impairment: serum creatinine level of 2.0 milligrams per deciliter (177 µmmol/L) or higher; and aspartate or alanine aminotransferase levels greater than three times the upper limit of the normal range; ? Patients with contraindications to olanzapine, including known drug allergies, Parkinson's disease, or dementia with Lewy bodies; ? Uncontrolled diabetes; ? Known history of central nervous system disease (e.g., brain metastases or epilepsy); ? Concomitant use of quinolone antibiotics or ketoconazole or itraconazole; ? Opioid or alcohol dependence; ? Myasthenia gravis; ? Acute or easy-to-occur closed-angle glaucomatous eye episodes; ? Severe chronic obstructive pulmonary disease; ? Unable to comprehend the content of the STAI questionnaire or do not understand the survey;

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;range of motion of hip and knee;postoperative consumption of opioids;Length of stay;Incidence of postoperative complications ;adverse reactions related to drugs;Patient satisfaction;

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