Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Instituto do Cancer do Estado de São Paulo
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- incidence of postoperative nausea and vomiting
Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
olanzapine tablets
PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY
Intervention: Olanzapine (Drug)
Starch tablets
PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY
Intervention: Olanzapine (Drug)
Outcomes
Primary Outcomes
incidence of postoperative nausea and vomiting
Time Frame: 0-24 hours
nausea and vomiting/ retching (dichotomous variable)
Secondary Outcomes
- incidence of side effects(24-48 hours)
- incidence of postoperative nausea and vomiting(24-48 hours)
- incidence of postoperative vomiting/retching(24-48 hours)
- incidence of postoperative nausea(24-48 hours)
- incidence of severe PONV(24-48 hours)
- incidence of nausea severity(24-48 hours)