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

NCT04411069 | Completed Phase 2

• 1 other identifier: NP 1336/18
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea; Postoperative Vomiting

Keywords

nausea; vomiting; chemoterapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changing in the institutional protocol

  from the begining to the study to the end of the study (2 years)

Study Arms (2)

Patients without previous CINV

NO INTERVENTION

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

Patients with previous CINV

OTHER

Patients who had previous nausea and vomiting induced by chemoterapy.

Drug: Droperidol

Interventions

Droperidol DRUG

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

Also known as: Intravenous droperidol

Patients with previous CINV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who underwent medium to large surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Cancer Institute of the State of Sao Paulo - ICESP

São Paulo, São Paulo, 01403010, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Droperidol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roger Chammas

  Instituto do Cancer do Estado de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient didn't know if he received the third anti emetic
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 2, 2020
• Study Start: February 20, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)