Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    1154
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
Updated on 26 May 2022

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.

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.

Details
Condition C.Surgical Procedure; Gastrointestinal
Treatment palonosteron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl, palonosteron, dexamethasone, and 0.9% NaCl
Clinical Study IdentifierNCT04853147
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
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