Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.
The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.
Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.
The primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.
The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.
For quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.
For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.
Data will be collected and managed using REDCap data capture tools
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine tablets | Experimental | PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY |
|
| Starch tablets | Placebo Comparator | PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | olanzapine 10 mg is given before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative nausea and vomiting | nausea and vomiting/ retching (dichotomous variable) | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of side effects | side effects | 0-6 hours |
| incidence of side effects | side effects | 0-24 hours |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roger Chammas | Instituto do Cancer do Estado de São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of the State of Sao Paulo - ICESP | São Paulo | São Paulo | 01403010 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 6, 2023 | |
| Reset | Mar 21, 2024 | |
| Release | Apr 7, 2025 | |
| Reset | Apr 24, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 6, 2023 | Mar 21, 2024 | |||
| Apr 7, 2025 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| incidence of side effects | side effects | 24-48 hours |
| incidence of postoperative nausea and vomiting | nausea and vomiting/ retching (dichotomous variable) | 0-6 hours |
| incidence of postoperative nausea and vomiting | nausea and vomiting/ retching (dichotomous variable) | 24-48 hours |
| incidence of postoperative nausea | nausea and vomiting/ retching (dichotomous variable) | 0-6 hours |
| incidence of postoperative nausea | nausea and vomiting/ retching (dichotomous variable) | 0-24 hours |
| incidence of postoperative nausea | nausea and vomiting/ retching (dichotomous variable) | 24-48 hours |
| incidence of postoperative vomiting/retching | vomiting/ retching (dichotomous variable) | 0-6 hours |
| incidence of postoperative vomiting/retching | vomiting/ retching (dichotomous variable) | 0-24 hours |
| incidence of postoperative vomiting/retching | vomiting/ retching (dichotomous variable) | 24-48 hours |
| incidence of severe PONV | This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important. | 0-6 hours |
| incidence of severe PONV | This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important. | 0-24 hours |
| incidence of severe PONV | This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important. | 24-48 hours |
| incidence of nausea severity | mild, moderate, or severe | 0-6 hours |
| incidence of nausea severity | mild, moderate, or severe | 0-24 hours |
| incidence of nausea severity | mild, moderate, or severe | 24-48 hours |
| Apr 24, 2025 |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |