PALONOSETRON X FOSAPREPITANT IN PONV

March 10, 2019 updated by: Estevão Braga, Hospital Federal de Bonsucesso

COMPARATIVE STUDY BETWEEN PALONOSETRON AND FOSAPREPITANT IN THE PROFILAXIA OF POSTOPERATIVE NAUSEA AND VOMITING IN WOMEN SUBMITTED TO VIDEOLAPAROSCOPIC COLECISTECTOMIES

Cholelithiasis (presence of gallbladder stones) is prevalent in 10 to 15% of the world population. This disease can lead to serious complications such as cholecystitis, cholangitis and pancreatitis. Video-laparoscopic cholecystectomy (CVL) is considered the gold standard treatment of this condition.

Despite ongoing research and development of new drugs and techniques, postoperative nausea and vomiting (PONV) are frequent, lead to unexpected hospitalizations, delay hospital discharge, increase hospital costs, and cause patient dissatisfaction. Video-laparoscopic surgeries are cited in the literature as a risk factor for PONV, with an incidence of up to 75% in cases where prophylactic drugs are not used.Through the simplified Apfel score, it is possible to determine the risk for PONV. This risk classification is based on four risk factors: female gender, non-smoking, postoperative use of opioids and previous history of PONV. The incidence of PONV would be 10%, 20%, 40%, 60% and 80%, respectively, if none, one, two, three or four risk factors are present.

Antiemetics recommended for prophylaxis of PONV in adults include 5-hydroxytryptamine (5-HT3) receptor antagonists (ondansetron, dolasetron, granisetron, tropisetron, ramosetron and palonosetron), neurokinin-1 (NK-1) receptor antagonists (aprepitant), (dendrohydrin and haloperidol), antihistamines (dimenhydrin and meclizine), and anticholinergics (scopolamine).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prospective, randomized and double-blind clinical trial will be performed at the Federal Hospital of Bonsucesso (HFB), Rio de Janeiro, RJ.

The Informed Consent Form (TCLE) will be presented and signed, on an outpatient basis, by each of the volunteer participants, who will be guided about the risks and benefits of the research, according to resolution CNS 466/12. A total of 100 female patients, aged between 18 and 60 years, ASA I and II, submitted to elective laparoscopic cholecystectomies, were randomly assigned to two groups: Group P (GP) will receive palonosetron 75 mcg and the other Group F GF), you will receive fosaprepitanto 150 mg. Palonosetron and fosaprepitanto are not standard medications in HFB. Both will be purchased and will be in the possession of the principal investigator, who undertakes to obey the current norms of the hospital institution and ensure the quality, storage and adequate stability of medications.

Patients will not receive preanesthetic medication. They will be monitored in the operating room with noninvasive blood pressure, electrocardioscopy, pulse oximetry, capnography, capnometry and bispectral index (BIS).

Patients will have a cannulated peripheral vein, be pre-oxygenated with oxygen at 100% for 5 minutes and anesthetic induction will be performed with intravenous administration (e.v.) of fentanyl 3 mcg / kg; lidocaine 1.5 mg / kg and propofol 2 mg / kg. Tracheal intubation will be facilitated after 3 minutes of administration of rocuronium 0.6 mg / kg e.v. After induction of anesthesia, the antiemetics, depending on the group studied, will be administered e.v. in solution containing 100 ml of 0.9% strength.

Maintenance of anesthesia will be with sevoflurane 2 L / min in 50% oxygen / air, with its concentration adjusted to maintain BIS between 40-60. Remifentanil 0.05 mcg / kg / min at 0.2 mcg / kg / min via e.v. may be given intraoperatively if the heart rate or blood pressure rises by more than 20% of the baseline values. Additional doses of rocuronium may also be given as needed. Patients will receive paracoxib 40 mg, dipyrone 50 mg / kg and ranitidine 50 mg e.v. after tracheal intubation. The surgical wound will be infiltrated with 20 ml of 0.5% ropivacaine before the sutures. The neuromuscular blockade will be reversed with neostigmine 0.04 mg / kg and atropine 0.02 mg / kg per e.v. Morphine 0.03 mg / kg e.v. will be given at the end of the surgery. The inflation of the pneumoperitoneum with CO2 (carbon dioxide), will have as limit abdominal pressure of 15 mmHg.

A physician not participating in the research will be aware of which antiemetic has been administered and will be responsible for the postoperative prescription of the patients. Both groups will have metoclopramide 10 mg e.v. as rescue medication for PONV.

For the purpose of the study, nausea will be defined as an unpleasant and involuntary sensation of vomiting, without the expulsion of stomach contents, and vomiting as expulsion of the stomach contents.

The patients will be visited by the research team 2, 6, 24 and 48 h after the end of the surgery, being questioned about the frequency and intensity of PONV, as well as other adverse effects. Researchers will not have access to prescription and medical records within the first 48 hours postoperatively.

After the last clinical evaluation, the researchers will analyze the prescription and note the use of morphine and rescue metoclopramide. They will also answer a question about the degree of satisfaction with the anti-emetic therapy used and will have 3 "Unsatisfied, satisfied or very satisfied" response options. Regarding the total cost of antiemetic therapy, it will be based on the ANVISA (National Health Surveillance Agency) table.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21041-030
        • Recruiting
        • Hospital Federal de Bonsucesso
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Núbia Verçosa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women
  • Non fumant
  • cholelitiasis

Exclusion Criteria:

  • severe heart, pulmonay, renal or liver diseases
  • Tabagism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palonosetrona
Palonosetron 75 mcg during the anesthesia
Drug: Palonosetron
75 mcg during the anesthesia
Active Comparator: Fosaprepitant
Fosaprepitant 150 mg during the anesthesia
Drug: Fosaprepitant
150 mg during the anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of complete responder
Time Frame: 48 hours
individuals without nausea or vomiting
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: the first postoperative 48 hours
questionnaire on the number of individual episodes of nausea
the first postoperative 48 hours
vomiting
Time Frame: the first postoperative 48 hours
questionnaire on the number of individual episodes of vomiting
the first postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Federal de Bonsucesso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 2, 2019

Primary Completion (Actual)

March 2, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89510518.6.0000.5253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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