Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients

Phase 2

Completed

• Conditions: Postoperative Nausea; Postoperative Nausea and Vomiting
• Interventions: Drug: Olanzapine

• Registration Number: NCT03631004
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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 Timeline

• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-11
• Study First Posted: 2018-08-15
• Study Start: 2018-10-01
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olanzapine tablets	Olanzapine	PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY
Starch tablets	Olanzapine	PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	0-24 hours	nausea and vomiting/ retching (dichotomous variable)

Secondary Outcome Measures

Name	Time	Method
incidence of side effects	24-48 hours	side effects
incidence of postoperative nausea and vomiting	24-48 hours	nausea and vomiting/ retching (dichotomous variable)
incidence of postoperative vomiting/retching	24-48 hours	vomiting/ retching (dichotomous variable)
incidence of postoperative nausea	24-48 hours	nausea and vomiting/ retching (dichotomous variable)
incidence of severe PONV	24-48 hours	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.
incidence of nausea severity	24-48 hours	mild, moderate, or severe

Trial Locations

Locations (1)

Cancer Institute of the State of Sao Paulo - ICESP; 🇧🇷 Sao Paulo, São Paulo, Brazil