As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.
Intervention 1. Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg, 2. Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. In the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.
Samsung Medical Center
Seoul, Seoul, South Korea
the incidence of Postoperative nausea and vomiting
yes or no
Time frame: during 24 hours after surgery
the incidence of Postoperative nausea and vomiting
yes or no
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery
the severity of Postoperative nausea and vomiting
numeric rating scale 0-10 and PONV impact scale
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
rescue antiemetics
dose
Time frame: during 24 hours after surgery
time to rescue antiemetics
the first administration time point of rescue antiemetics
Time frame: during 24 hours after surgery
postoperative pain at rest and couging
numeric rating scale 0-10
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
opioid consumption
morphine equivalent dose
Time frame: during 24 hours after surgery
Any adverse event
yes or no
Time frame: during 24 hours after surgery
Time to normal diet
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time of succes of normal diet
Time frame: during 24 hours after surgery
Qualityof recovery from surgery and anesthesia
QoR 15K questionairre
Time frame: during 24 hours after surgery
Time to first flatus
gas out time pointsyes or no
Time frame: during in hospital stay, an average of 5 days