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

Samsung Medical Center

Status: Invitation-only

Conditions: Laparoscopy; Postoperative Nausea and Vomiting; Gynecologic Surgical Procedures

Treatments: Drug: fosaprepitant; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05773950

SMC2022-12-050-001

Details and patient eligibility

About

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.

Full 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,

Enrollment: 144 estimated patients

Sex: Female

Ages: 19 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Dual therapy group

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline

Triple therapy group

Experimental group

Description:

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.

Treatment:

Drug: fosaprepitant