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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

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 16, 2018
Last Update Posted Date March 12, 2019
Estimated Study Start Date  ICMJE March 2, 2019
Actual Primary Completion Date March 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Number of complete responder [ Time Frame: 48 hours ]
individuals without nausea or vomiting
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03586817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Nausea [ Time Frame: the first postoperative 48 hours ]
    questionnaire on the number of individual episodes of nausea
  • vomiting [ Time Frame: the first postoperative 48 hours ]
    questionnaire on the number of individual episodes of vomiting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PALONOSETRON X FOSAPREPITANT IN PONV
Official Title  ICMJE COMPARATIVE STUDY BETWEEN PALONOSETRON AND FOSAPREPITANT IN THE PROFILAXIA OF POSTOPERATIVE NAUSEA AND VOMITING IN WOMEN SUBMITTED TO VIDEOLAPAROSCOPIC COLECISTECTOMIES
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).

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Nausea and Vomiting, Postoperative
Intervention  ICMJE
  • Drug: Palonosetron
    75 mcg during the anesthesia
  • Drug: Fosaprepitant
    150 mg during the anesthesia
Study Arms  ICMJE
  • Active Comparator: Palonosetrona
    Palonosetron 75 mcg during the anesthesia
    Intervention: Drug: Palonosetron
  • Active Comparator: Fosaprepitant
    Fosaprepitant 150 mg during the anesthesia
    Intervention: Drug: Fosaprepitant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date March 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women
  • Non fumant
  • cholelitiasis

Exclusion Criteria:

  • severe heart, pulmonay, renal or liver diseases
  • Tabagism
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Fenale
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03586817
Other Study ID Numbers  ICMJE 89510518.6.0000.5253
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Estevão Braga, Hospital Federal de Bonsucesso
Study Sponsor  ICMJE Hospital Federal de Bonsucesso
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Federal de Bonsucesso
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP