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

Not Applicable

• Conditions: Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures; Laparoscopy
• Interventions: Drug: normal saline; Drug: fosaprepitant

• Registration Number: NCT05773950
• Lead Sponsor: Samsung Medical Center

Brief 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,

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Study Start: 2023-08-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual therapy group	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. 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.
Triple therapy group	fosaprepitant	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 experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes. 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.

Primary Outcome Measures

Name	Time	Method
the incidence of Postoperative nausea and vomiting	during 24 hours after surgery	yes or no

Secondary Outcome Measures

Name	Time	Method
the severity of Postoperative nausea and vomiting	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
rescue antiemetics	during 24 hours after surgery	dose
opioid consumption	during 24 hours after surgery	morphine equivalent dose
Any adverse event	during 24 hours after surgery	yes or no
Qualityof recovery from surgery and anesthesia	during 24 hours after surgery	QoR 15K questionairre
the incidence of Postoperative nausea and vomiting	during post-anesthesia care unit stay, during 6 hours after surgery	yes or no
Time to first flatus	during in hospital stay, an average of 5 days	gas out time pointsyes or no
postoperative pain at rest and couging	during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery	numeric rating scale 0-10
Time to normal diet	during 24 hours after surgery	time of succes of normal diet
time to rescue antiemetics	during 24 hours after surgery	the first administration time point of rescue antiemetics

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of