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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05773950
Other study ID # SMC2022-12-050-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 18, 2023
Est. completion date March 30, 2024

Study information

Verified date August 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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,


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 144
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of Postoperative nausea and vomiting yes or no during 24 hours after surgery
Secondary the incidence of Postoperative nausea and vomiting yes or no during post-anesthesia care unit stay, during 6 hours after surgery
Secondary 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
Secondary rescue antiemetics dose during 24 hours after surgery
Secondary time to rescue antiemetics the first administration time point of rescue antiemetics during 24 hours after surgery
Secondary 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
Secondary opioid consumption morphine equivalent dose during 24 hours after surgery
Secondary Any adverse event yes or no during 24 hours after surgery
Secondary Time to normal diet time of succes of normal diet during 24 hours after surgery
Secondary Qualityof recovery from surgery and anesthesia QoR 15K questionairre during 24 hours after surgery
Secondary Time to first flatus gas out time pointsyes or no during in hospital stay, an average of 5 days
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