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

Study Overview
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Brief Summary
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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
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Intervention Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg, Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,

Official Title
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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

Conditions
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Laparoscopy, Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures

Intervention / Treatment
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* Drug: fosaprepitant
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dual therapy group<br>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<br>* 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.<br>* Other names: placebo;|
| Experimental: Triple therapy group<br>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<br>* 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.<br>* Other names: emend;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, fosaprepitant, dexamethasone, palonosetron