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

Postoperative Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411069
• Other study ID #: NP 1336/18
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: May 2021
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Patient undergoing chemotherapy before surgery;

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Brazil	Cancer Institute of the State of Sao Paulo - ICESP	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)