Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

Sun Yat-sen University

Status and phase

Completed

Phase 3

Conditions

C.Surgical Procedure; Gastrointestinal

Treatments

Drug: palonosetron, dexamethasone, and 0.9% NaCl

Drug: palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl

Study type

Interventional

Funder types

Other

Identifiers

NCT04853147

E2020170

Details and patient eligibility

About

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. Palonosetron 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 palonosetron and dexamethasone to prevent PONV.

Full description

This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.

Enrollment

1,154 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.