Postoperative Nausea and Vomiting Clinical Trial
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
Verified date | August 2023 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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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