NCT05773950

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 19 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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,

Conditions

• Postoperative Nausea and Vomiting
• Gynecologic Surgical Procedures
• Laparoscopy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2023-08-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-17
• Last updated: 2025-03-30

Locations

1 site across 1 country: South Korea