Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital

Study Overview
=================
Brief Summary
-----------------
Previous history of nausea and vomiting induced by prior chemotherapy still not included as predictive factor of postoperative nausea and vomiting, although has been demonstrated that has influence in postoperative outcome. The project aims to evaluate the efficacy of a simplified algorithm in prevention postoperative nausea and vomiting , with pacients with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium or large surgery.

Detailed Description
-----------------
Quasi-experimental study, with evaluation after the application of a specific postoperative nausea and vomiting prevention algorithm for cancer patients. The study will be carried out in 2 phases: Phase 1: Team training. In this phase, a protocol was established for PONV prophylaxis, using two questions: Patient undergoing chemotherapy before surgery; Patient presented chemotherapy induced nausea and vomiting (CINV). If the answer is yes to both questions, the anesthetist administers 3 antiemetics (4mg dexametasone, 4mg ondansetron and 0,625mg droperidol). If the answer is no to one of the questions, the anesthetist administers 2 antiemetics (4mg dexametasone and 4mg ondansetron); In this phase, educational measures will be implemented by team meetings and individual approach of all anesthesiologists at ICESP to present the study project and the algorithm. A summary of the the study will be sent daily through the social network Whats App®. The number of patients was calculated taking into account adherence to the new prophylaxis protocol for post-operative nausea and vomiting. If we consider an alpha error of 5% and test power of 80%, to have a NVPO reduction of 41% (current overall incidence) to 25% (incidence after protocol adherence) in high-risk patients, we need to study 270 patients (135 each group adherence and non-adherence to the protocol). Phase 2: Post-training assessment. In the second phase of the study, after the end of the dissemination of the protocol among doctors, the patients will be evaluated on the first postoperative day. The following variables were analyzed: sex, race, age, body mass index, general state of American Society of Anesthesiologist, Apfel scale, type of surgery and anesthesia, use and type of opioids, history of chemotherapy induced nausea and vomiting, type of antiemetics used in the operating room and in the first postoperative day, duration of anesthesia and surgery and nausea and vomiting in 6 and 24 hours after surgery.

Official Title
-----------------
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital

Conditions
-----------------
Postoperative Nausea, Postoperative Vomiting

Intervention / Treatment
-----------------
* Drug: Droperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent medium to large surgery Exclusion Criteria: Patients who are unable to communicate (orotracheal intubation after the surgery, confusion or agitation) or understand the Portuguese language; Insulin dependent patients Patients who underwent emergency surgery and neurosurgery Pacients who had an increased QT interval on the electrocardiogram History of allergy to dexametasone, ondansetron or droperidol Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients without previous CINV<br>Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery | |
| Other: Patients with previous CINV<br>Patients who had previous nausea and vomiting induced by chemoterapy. | Drug: Droperidol<br>* Pacients who had nausea and vomiting induced by chemotherapy will receive three anti emetic drugs: 4mg dexametasone, 4 mg ondansetron and 0,625 mg droperidol<br>* Other names: Intravenous droperidol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting | record of any episode of nausea and or vomiting in the 24 postoperative hours | from 0 to 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing in the institutional protocol | number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room | from the begining to the study to the end of the study (2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nausea, vomiting, chemoterapy