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Trial record 7 of 9 for:    MECLIZINE

PALONOSETRON X FOSAPREPITANT IN PONV

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ClinicalTrials.gov Identifier: NCT03586817
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Estevão Braga, Hospital Federal de Bonsucesso

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Nausea and Vomiting, Postoperative Drug: Palonosetron Drug: Fosaprepitant Phase 4

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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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COMPARATIVE STUDY BETWEEN PALONOSETRON AND FOSAPREPITANT IN THE PROFILAXIA OF POSTOPERATIVE NAUSEA AND VOMITING IN WOMEN SUBMITTED TO VIDEOLAPAROSCOPIC COLECISTECTOMIES
Estimated Study Start Date : March 2, 2019
Actual Primary Completion Date : March 2, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of complete responder [ Time Frame: 48 hours ]
    individuals without nausea or vomiting


Secondary Outcome Measures :
  1. Nausea [ Time Frame: the first postoperative 48 hours ]
    questionnaire on the number of individual episodes of nausea

  2. vomiting [ Time Frame: the first postoperative 48 hours ]
    questionnaire on the number of individual episodes of vomiting



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Fenale
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women
  • Non fumant
  • cholelitiasis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586817


Locations
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Brazil
Hospital Federal de Bonsucesso Recruiting
Rio de Janeiro, Brazil, 21041-030
Contact: Estêvão LC Braga, Md    5521998549109    estbraga@hotmail.com   
Contact: Ismar L Cavalcanti, PhD    5521999822993    Iismarcavalcanti@gmail.com   
Sub-Investigator: Núbia Verçosa, PhD         
Sponsors and Collaborators
Hospital Federal de Bonsucesso

Publications:
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Responsible Party: Estevão Braga, Clinical Professor, Hospital Federal de Bonsucesso
ClinicalTrials.gov Identifier: NCT03586817     History of Changes
Other Study ID Numbers: 89510518.6.0000.5253
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Palonosetron
Fosaprepitant
Aprepitant
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists