Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosteron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosteron and dexamethasone to prevent PONV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone acetate; Fosaprepitant

Criteria

Inclusion Criteria:

• Age ≥18 years and Age ≤75 years;

• Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;

• The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.

Exclusion Criteria:

• The American Society of Anesthesiologists (ASA) rating is >3;

• Severe hepatic dysfunction(the score of Child-Pugh is >9);

• With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;

• Take medications with known antiemetic properties preoperatively ;

• With mental disorder, or not be able to communicate ;

• Pregnant women or nursing mothers.