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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05773950
• Other study ID #: SMC2022-12-050-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: August 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 144
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgical Procedures
• Laparoscopy
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of Postoperative nausea and vomiting	yes or no	during 24 hours after surgery
Secondary	the incidence of Postoperative nausea and vomiting	yes or no	during post-anesthesia care unit stay, during 6 hours after surgery
Secondary	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
Secondary	rescue antiemetics	dose	during 24 hours after surgery
Secondary	time to rescue antiemetics	the first administration time point of rescue antiemetics	during 24 hours after surgery
Secondary	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
Secondary	opioid consumption	morphine equivalent dose	during 24 hours after surgery
Secondary	Any adverse event	yes or no	during 24 hours after surgery
Secondary	Time to normal diet	time of succes of normal diet	during 24 hours after surgery
Secondary	Qualityof recovery from surgery and anesthesia	QoR 15K questionairre	during 24 hours after surgery
Secondary	Time to first flatus	gas out time pointsyes or no	during in hospital stay, an average of 5 days