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

Primary Purpose

Postoperative Nausea, Postoperative Vomiting

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Droperidol
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea focused on measuring nausea, vomiting, chemoterapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cancer Institute of the State of Sao Paulo - ICESP

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Patients without previous CINV

Patients with previous CINV

Arm Description

Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery

Patients who had previous nausea and vomiting induced by chemoterapy.

Outcomes

Primary Outcome Measures

postoperative nausea and vomiting
record of any episode of nausea and or vomiting in the 24 postoperative hours

Secondary Outcome Measures

Changing in the institutional protocol
number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room

Full Information

First Posted
May 18, 2020
Last Updated
May 17, 2021
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04411069
Brief Title
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital
Official Title
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea, Postoperative Vomiting
Keywords
nausea, vomiting, chemoterapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The patient didn't know if he received the third anti emetic
Allocation
Non-Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients without previous CINV
Arm Type
No Intervention
Arm Description
Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery
Arm Title
Patients with previous CINV
Arm Type
Other
Arm Description
Patients who had previous nausea and vomiting induced by chemoterapy.
Intervention Type
Drug
Intervention Name(s)
Droperidol
Other Intervention Name(s)
Intravenous droperidol
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
record of any episode of nausea and or vomiting in the 24 postoperative hours
Time Frame
from 0 to 24 postoperative hours
Secondary Outcome Measure Information:
Title
Changing in the institutional protocol
Description
number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room
Time Frame
from the begining to the study to the end of the study (2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Chammas
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Institute of the State of Sao Paulo - ICESP
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01403010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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