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

NCT ID: NCT05773950

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-18
• Study Completion Date: 2025-12-31

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,

Conditions

Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures; Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Dual therapy group

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: 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.

Triple therapy group

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.

Group Type: EXPERIMENTAL

fosaprepitant

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

emend; placebo

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Heejoon Jeong

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

SMC2022-12-050-001

Identifier Type: -

Identifier Source: org_study_id