Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery
Phase: PHASE3
Conditions: C.Surgical Procedure; Gastrointestinal
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Official Title：Triple Combination of Fosaprepitant,
Dexamethasone and Palonosetron Versus Combination of
Dexamethasone and Palonosetron for the Prevention of
Postoperative Nausea and Vomiting in Patients Undergoing
Laparoscopic Gastrointestinal Surgery
NCT number：NCT04853147
Date of the document：18/04/2021

This study is a single-center, randomised, controlled, double-blind,
parallel-group clinical trial
Study design
Patients is randomized in a 1:1 ratio to receive either triple therapy or doublet
therapy using computer-generated codes with randomly block sizes. Randomization is
stratified based on the apfel score (3 or 4). Triple therapy is combined with
fosaprepitant plus dexamethesone and palonosetron. doublet therapy is combined with
placebo (normal saline) plus dexamethesone and palonosteron. The study drug is
prepared by the nurses in anesthetic pharmacy who do not participate in this trail.
Allocation is concealed from the investigators, patients and surgeons. Fosaprepitant
and placebo were contained in identical intravenous infusion bags. Study drug or
placebo infusion was initiated before anesthetic induction. Dexamethasone and
palonosetron are injected at induction in both group.
Anaesthetic protocol
A standardized total intravenous anaesthetic protocol will be applied to all
patients. General anaesthesia will be induced with intravenous administration of
propofol, cisatracurium and remifentanil. The anesthesia will be maintained by
propofol and remifentanil under monitoring of the bispectral index. Standard patient
monitoring including ECG, pulse oximetry, capnography, blood pressure will be
performed. Before skin incision, non-steroidal anti-inflammatory drug (NSAID) will
be injected for preemptive analgesia. At the end of surgery, ropivacaine was used as
local infiltration anesthesia around the wound and intravenous patient-controlled
analgesia containing hydromorphone and NSAID will be connected to patients at the
end of surgery.
Statistical analysis
The hypothesis of this study is that the proportion of participants with PONV
for triple therapy will be significantly lower than that for doublet therapy. A sample
size of 1154 patients will be selected on the basis of the following assumptions: (1)
the proportion of participants with PONV is about 50% in doublet therapy and is

estimated to 40% in triple therapy, (2) α =0.05, (3) power 90% and (4) missed
follow-up rate 10%.
Subgroup analysis will be stratified by apfel score, surgical site, or age
respectively.