Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy
Conditions
Keywords
PONV, fosaprepitant, dexamethasone, palonosetron
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,
Interventions
DRUGfosaprepitant
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.
DRUGnormal 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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized placebo-controlled trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of Postoperative nausea and vomiting | during 24 hours after surgery | yes or no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the severity of Postoperative nausea and vomiting | during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery | numeric rating scale 0-10 and PONV impact scale |
| rescue antiemetics | during 24 hours after surgery | dose |
| time to rescue antiemetics | during 24 hours after surgery | the first administration time point of rescue antiemetics |
| postoperative pain at rest and couging | during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery | numeric rating scale 0-10 |
| the incidence of Postoperative nausea and vomiting | during post-anesthesia care unit stay, during 6 hours after surgery | yes or no |
| Any adverse event | during 24 hours after surgery | yes or no |
| Time to normal diet | during 24 hours after surgery | time of succes of normal diet |
| Qualityof recovery from surgery and anesthesia | during 24 hours after surgery | QoR 15K questionairre |
| Time to first flatus | during in hospital stay, an average of 5 days | gas out time pointsyes or no |
| opioid consumption | during 24 hours after surgery | morphine equivalent dose |
Countries
South Korea
Outcome results
None listed