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

Sponsor

Instituto do Cancer do Estado de São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT04411069

Collaborator

(none)

270

Enrollment

Location

Arms

24.9

Actual Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea Postoperative Vomiting	Drug: Droperidol	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

270 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

The patient didn't know if he received the third anti emetic

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 20, 2019

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Patients without previous CINV 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 Patients who had previous nausea and vomiting induced by chemoterapy.	Drug: Droperidol 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 Other Names: Intravenous droperidol

Arm

Intervention/Treatment

No Intervention: Patients without previous CINV

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

Patients who had previous nausea and vomiting induced by chemoterapy.

Drug: Droperidol

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

Other Names:

Intravenous droperidol

Outcome Measures

Primary Outcome Measures

postoperative nausea and vomiting [from 0 to 24 postoperative hours]
record of any episode of nausea and or vomiting in the 24 postoperative hours

Secondary Outcome Measures

Changing in the institutional protocol [from the begining to the study to the end of the study (2 years)]
number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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