Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05773950

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Postoperative Nausea and Vomiting Gynecologic Surgical Procedures Laparoscopy Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

19 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

Intervention

  • Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg,
  • Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosaprepitant

Drug

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.

Other names: emend

normal saline

Drug

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.

Other names: placebo

Primary outcomes

  1. the incidence of Postoperative nausea and vomiting

    Time frame: during 24 hours after surgery

    yes or no

Secondary outcomes

  1. the incidence of Postoperative nausea and vomiting

    Time frame: during post-anesthesia care unit stay, during 6 hours after surgery

    yes or no

  2. the severity of Postoperative nausea and vomiting

    Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery

    numeric rating scale 0-10 and PONV impact scale

  3. rescue antiemetics

    Time frame: during 24 hours after surgery

    dose

  4. time to rescue antiemetics

    Time frame: during 24 hours after surgery

    the first administration time point of rescue antiemetics

  5. postoperative pain at rest and couging

    Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery

    numeric rating scale 0-10

  6. opioid consumption

    Time frame: during 24 hours after surgery

    morphine equivalent dose

  7. Any adverse event

    Time frame: during 24 hours after surgery

    yes or no

  8. Time to normal diet

    Time frame: during 24 hours after surgery

    time of succes of normal diet

  9. Qualityof recovery from surgery and anesthesia

    Time frame: during 24 hours after surgery

    QoR 15K questionairre

  10. Time to first flatus

    Time frame: during in hospital stay, an average of 5 days

    gas out time pointsyes or no

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.