PALONOSETRON X FOSAPREPITANT IN PONV

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Federal de Bonsucesso
• Treatments: Anesthetics; Aprepitant; Fosaprepitant; Palonosetron

Criteria

Inclusion Criteria:

• women

• Non fumant

• cholelitiasis

Exclusion Criteria:

• severe heart, pulmonay, renal or liver diseases

• Tabagism