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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.
Intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual therapy group | Placebo Comparator | 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. 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. |
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| Triple therapy group | Experimental | 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 experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosaprepitant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of Postoperative nausea and vomiting | yes or no | during 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of Postoperative nausea and vomiting | yes or no | during post-anesthesia care unit stay, during 6 hours after surgery |
| the severity of Postoperative nausea and vomiting | numeric rating scale 0-10 and PONV impact scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
| D000077608 | Aprepitant |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized placebo-controlled trial
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| normal saline | Drug | 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. |
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| during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery |
| rescue antiemetics | dose | during 24 hours after surgery |
| time to rescue antiemetics | the first administration time point of rescue antiemetics | during 24 hours after surgery |
| 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 |
| opioid consumption | morphine equivalent dose | during 24 hours after surgery |
| Any adverse event | yes or no | during 24 hours after surgery |
| Time to normal diet | time of succes of normal diet | during 24 hours after surgery |
| Qualityof recovery from surgery and anesthesia | QoR 15K questionairre | during 24 hours after surgery |
| Time to first flatus | gas out time pointsyes or no | during in hospital stay, an average of 5 days |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |