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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Nausea and Vomiting; Laparoscopy; Gynecologic Surgical Procedures
• Intervention / Treatment: Drug: normal saline; Drug: fosaprepitant

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heejoon Jeong, MD; Phone Number: 821087282414; Email: heejoonjeong@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.; Other Names: placebo
Experimental: 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.	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.; Other Names: emend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of Postoperative nausea and vomiting	yes or no	during 24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: dexamethasone; PONV; palonosetron; fosaprepitant
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant; Fosaprepitant
• Other Study ID Numbers: SMC2022-12-050-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No