drugset / Trial / NCT03586817

PALONOSETRON X FOSAPREPITANT IN PONV

NCT03586817

Phase 4 Unknown 100 enrolled Bonsucesso Federal Hospital
RandomizedParallel-groupSingle-blindPrevention

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).

Timeline

Start
2019-03-02
Primary completion
2019-03-02
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fosaprepitant Other / unclassified 150 mg Intravenous
Comparator Palonosetron Other / unclassified 75 ug Intravenous

Indications

No indication recorded.