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

NCT05773950 | Enrolling By Invitation

• 1 other identifier: SMC2022-12-050-001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures; Laparoscopy

Keywords

PONV; fosaprepitant; dexamethasone; palonosetron

Outcome Measures

Primary Outcomes (1)

• the incidence of Postoperative nausea and vomiting

  yes or no

  during 24 hours after surgery

Secondary Outcomes (10)

• the incidence of Postoperative nausea and vomiting

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

• the severity of Postoperative nausea and vomiting

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

• rescue antiemetics

  during 24 hours after surgery

• time to rescue antiemetics

  during 24 hours after surgery

• postoperative pain at rest and couging

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

Study Arms (2)

Dual therapy group

PLACEBO COMPARATOR

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.

Drug: normal saline

Triple therapy group

EXPERIMENTAL

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.

Drug: fosaprepitant

Interventions

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.

Also known as: emend

Triple therapy group

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.

Also known as: placebo

Dual therapy group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing laparoscopic gynecological surgery.
• Adults between the ages of 18 and 50
• American Society of Anesthesiologists Physical Status (ASA physical status I, II

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

fosaprepitant; Aprepitant; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: August 18, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-01

Locations

KR (1)