Clinical trial NCT05773950: Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Gynecologic Surgical Procedures
Laparoscopy
Keywords: PONV
fosaprepitant
dexamethasone
palonosetron
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 144
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial
Primary purpose: PREVENTION

Brief 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.

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,

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

Primary outcomes:
measure: the incidence of Postoperative nausea and vomiting
timeFrame: during 24 hours after surgery
Secondary outcomes:
measure: the incidence of Postoperative nausea and vomiting
timeFrame: during post-anesthesia care unit stay, during 6 hours after surgery
measure: the severity of Postoperative nausea and vomiting
timeFrame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
measure: rescue antiemetics
timeFrame: during 24 hours after surgery
measure: time to rescue antiemetics
timeFrame: during 24 hours after surgery
measure: postoperative pain at rest and couging
timeFrame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
measure: opioid consumption
timeFrame: during 24 hours after surgery
measure: Any adverse event
timeFrame: during 24 hours after surgery
measure: Time to normal diet
timeFrame: during 24 hours after surgery
measure: Qualityof recovery from surgery and anesthesia
timeFrame: during 24 hours after surgery
measure: Time to first flatus
timeFrame: during in hospital stay, an average of 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: