PALONOSETRON X FOSAPREPITANT IN PONV
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|ClinicalTrials.gov Identifier: NCT03586817|
Recruitment Status : Unknown
Verified March 2019 by Estevão Braga, Hospital Federal de Bonsucesso.
Recruitment status was: Recruiting
First Posted : July 16, 2018
Last Update Posted : March 12, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: Palonosetrona
Palonosetron 75 mcg during the anesthesia
75 mcg during the anesthesia
Active Comparator: Fosaprepitant
Fosaprepitant 150 mg during the anesthesia
150 mg during the anesthesia
- Number of complete responder [ Time Frame: 48 hours ]individuals without nausea or vomiting
- 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
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