UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057772 |
|---|---|
| Receipt number | R000065725 |
| Scientific Title | Efficacy and safety of olanzapine for the prevention of post operative nausea and vomiting after arthroplasty |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2026/03/07 10:38:17 |
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Basic information
Public title
Efficacy of olanzapine for the prevention of post operative nausea and vomiting after arthroplasty
Acronym
OLPONV
Scientific Title
Efficacy and safety of olanzapine for the prevention of post operative nausea and vomiting after arthroplasty
Scientific Title:Acronym
OLPONV
Region
| Japan |
Condition
Condition
Post operative nausea and vomiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In knee or hip arthroplasty(TKA THA), severe pain often necessitates high doses of opioids, which frequently cause nausea and vomiting. These symptoms not only reduce quality of life but also interfere with rehabilitation and increase the use of medical resources. Reducing opioid use to avoid side effects can lead to inadequate pain control, further delaying rehabilitation. Since many patients are elderly, prolonged bed rest can cause complications such as disuse syndrome, cognitive decline, and pulmonary embolism, negatively affecting prognosis.
Olanzapine, an atypical antipsychotic with antiemetic effects through multiple receptor antagonism, has shown effectiveness against opioid- and chemotherapy-induced nausea and vomiting. While its efficacy has been demonstrated in younger women undergoing gynecologic surgery, it has not been studied in the elderly population typical of knee arthroplasty. This study aims to evaluate the effectiveness and safety of olanzapine in preventing nausea and vomiting in elderly patients undergoing total arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence and frequency of nausea and vomiting, administration of rescue anti-emetics within 6-hrs, 6-12 hrs and 12-24hrs after the surgery
Key secondary outcomes
Food intake status on the morning and afternoon after surgery; frequency of use of analgesics outside of the clinical pathway; pain NRS (Numerical Rating Scale) scores; RASS (Richmond Agitation-Sedation Scale) score on the morning after surgery; wheelchair transfer assistance score on the day after surgery (as an indicator of rehabilitation progress); patient satisfaction; adverse events and their frequency.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The allocated participant will orally take encapsulated crushed olanzapine (OD tablet) 5.0 mg two hours prior to surgery.
Interventions/Control_2
The allocated participant will take orally 300 mg of lactose with colored-powder matched to that of olanzapine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Scheduled knee arthroplasty 2)Use of subarachnoid morphine 3)ASA-PS class 1 or 2 4) Age equals or under 80 5)Appel score more than 3
Key exclusion criteria
1)Diabetic patient 2)Use of anti-psychotics (anxiolytics, sleep induction medications are excluded) 3)known allergy to trial drugs, opioids and anesthetics 4)Use of anti-emetics 24hrs before surgery 5)Inappropriate use of the drug of this trial due to conditions such as past or familial history of malignant syndrome and extrapyramidal symptoms. 6)Unable to consent or understand the trial.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tsunehisa |
| Middle name | |
| Last name | Namba |
Organization
JA Yoshida General Hospital
Division name
Department of Anesthesia
Zip code
731-0501
Address
3666 Yoshida Yoshida-chou Akitakada-city Hiroshima
TEL
0826-42-0636
drnamba@mac.com
Public contact
Name of contact person
| 1st name | Tsunehisa |
| Middle name | |
| Last name | Namba |
Organization
JA Yoshida General Hospital
Division name
Department of Anesthesia
Zip code
731-0501
Address
3666 Yoshida Yoshida Akitakada Hiroshima
TEL
0826-42-0636
Homepage URL
drnamba@mac.com
Sponsor or person
Institute
JA Yoshida General Hospital
Institute
Department
Personal name
Funding Source
Organization
JA Yoshida general Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JA Yoshida General Hospital
Address
3666 Yoshida Yoshida Akitakada Hiroshima
Tel
0826-42-0636
drnamba@mac.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JA吉田総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.dropbox.com/scl/fi/628cimzl2dyd1c8be5isy/PONV_result.pdf?rlkey=ckdql685nukoenhte1njv0m62
Number of participants that the trial has enrolled
30
Results
1) The control group, olanzapine 2.5 mg group, and olanzapine 5 mg group all suppressed PONV in a dose-dependent manner (Fisher's exact test p=0.001).
2) No increase in adverse events was observed among the three tested groups (Fisher's exact test p=0.527).
3) The absolute risk reduction for PONV suppression by olanzapine 5 mg was 0.318 (95% CI 0.124 to 0.513), with an NNT of 4.
Translated with DeepL.com (free version)
Results date posted
| 2025 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No increase in adverse events was observed among 2.5mg and 5mg olanzapine groups (Fisher's exact test p=0.527).
Outcome measures
The olanzapine 2.5 mg group, and olanzapine 5 mg group both suppressed PONV in a dose-dependent manner (Fisher's exact test p=0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 10 | Month | 31 | Day |
Other
Other related information
An interim analysis of 30 patients was conducted on September 5, 2025. No statistically significant difference was observed in the primary endpoint, defined as the occurrence of at least one episode of nausea or vomiting, with an odds ratio of 1.29 (95% CI, 0.20-8.85).
Similarly, no significant differences were found in the secondary endpoints.
However, as the incidence of adverse events tended to be lower in the olanzapine group (odds ratio, 0.243; 95% CI, 0.030-1.48), approval was obtained from the ethics committee to increase the olanzapine dose to 5.0 mg and to conduct a subsequent re-evaluation.
In the additional trial using olanzapine 5 mg, the absolute risk reduction for the primary endpoint was 0.273 (95% CI 0.01-0.536), yielding an NNT=4 and demonstrating a significant effect. For adverse events, the risk ratio was 1.71 (95% CI 0.71-4.14), showing no significant increase. Therefore we planned to analyze and report the data combining the two clinical tests.
Management information
Registered date
| 2025 | Year | 05 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065725
