Clinical trial NCT03631004: Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
Official title: Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Nausea
Postoperative Nausea and Vomiting
Keywords: nausea and vomiting
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion criteria:

* Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia
* Patients aged between 18 and 60 years
* Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)
* Patients with a history of chemotherapy-induced nausea and vomiting.

Exclusion criteria:

* Pregnancy or Lactation
* Current use of typical anti-psychotic medications or atypical
* History of allergy to olanzapine
* Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning
* History of severe ventricular arrhythmia (eg, VT or VF)
* Heart Failure Class II or greater second NYHA
* Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning
* Narrow angle glaucoma
* Parkinson's disease
* Dementia
* Inability to swallow medicines
* QT interval history greater than 450ms or torsades de pointes
* Patient does not want to participate in the study
* Videolaparoscopy surgery
* Contraindication for neuraxial block

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 0-24 hours
Secondary outcomes:
measure: incidence of side effects
timeFrame: 0-6 hours
measure: incidence of side effects
timeFrame: 0-24 hours
measure: incidence of side effects
timeFrame: 24-48 hours
measure: incidence of postoperative nausea and vomiting
timeFrame: 0-6 hours
measure: incidence of postoperative nausea and vomiting
timeFrame: 24-48 hours
measure: incidence of postoperative nausea
timeFrame: 0-6 hours
measure: incidence of postoperative nausea
timeFrame: 0-24 hours
measure: incidence of postoperative nausea
timeFrame: 24-48 hours
measure: incidence of postoperative vomiting/retching
timeFrame: 0-6 hours
measure: incidence of postoperative vomiting/retching
timeFrame: 0-24 hours
measure: incidence of postoperative vomiting/retching
timeFrame: 24-48 hours
measure: incidence of severe PONV
timeFrame: 0-6 hours
measure: incidence of severe PONV
timeFrame: 0-24 hours
measure: incidence of severe PONV
timeFrame: 24-48 hours
measure: incidence of nausea severity
timeFrame: 0-6 hours
measure: incidence of nausea severity
timeFrame: 0-24 hours
measure: incidence of nausea severity
timeFrame: 24-48 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Cancer Institute of the State of Sao Paulo - ICESP
state: São Paulo
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Roger Chammas
role: STUDY_DIRECTOR
References: