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Clinical Trials in South Korea / NCT05773950
Enrolling by invitation Not applicable

Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention

NCT05773950 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2023-08-18
Last updated
2025-03-30

Condition(s) studied

Postoperative Nausea and VomitingGynecologic Surgical ProceduresLaparoscopy

Investigational drug(s) / intervention(s)

fosaprepitant →normal saline

fosaprepitant: 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.

normal saline: 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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
49 Years
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing laparoscopic gynecological surgery. * Adults between the ages of 18 and 50 * American Society of Anesthesiologists Physical Status (ASA physical status I, II Exclusion Criteria: * American Association of Anesthesiologists physical standards (ASA physical status III or higher) * Children under the age of 19 * Adults over 49 years of age * Diabetes Mellitus * Pregnant or lactating women * Patients with a history of allergy or contraindications for use of the study drug * Patients who did not understand this study or expressed their refusal. * Patients with a history of serious psychologic disease that may affect the patient evaluation * Patients taking serotonergic drugs

Primary outcome measure(s)

  • the incidence of Postoperative nausea and vomiting — during 24 hours after surgery
    yes or no

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul Seoul

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05773950 on ClinicalTrials.gov ↗ ← All trials in South Korea