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Enrolling by invitation NCT05773950

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

No phase Interventional Postoperative Nausea and Vomiting Gynecologic Surgical Procedures Laparoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fosaprepitant, normal saline.
Who it may be relevant to
Registry conditions: Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy. Basic parameters: 19 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

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,

Interventions

  • 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.
  • 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.

Primary outcome measures

  • the incidence of Postoperative nausea and vomiting [Time frame: during 24 hours after surgery]
Secondary outcome measures (10)
  • the incidence of Postoperative nausea and vomiting [Time frame: during post-anesthesia care unit stay, during 6 hours after surgery]
  • the severity of Postoperative nausea and vomiting [Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
  • rescue antiemetics [Time frame: during 24 hours after surgery]
  • time to rescue antiemetics [Time frame: during 24 hours after surgery]
  • postoperative pain at rest and couging [Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery]
  • opioid consumption [Time frame: during 24 hours after surgery]
  • Any adverse event [Time frame: during 24 hours after surgery]
  • Time to normal diet [Time frame: during 24 hours after surgery]
  • Qualityof recovery from surgery and anesthesia [Time frame: during 24 hours after surgery]
  • Time to first flatus [Time frame: during in hospital stay, an average of 5 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT05773950 · SMC2022-12-050-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗