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The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
Study is performed during 24 hours after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aprepitant plus palonosetron | Experimental | aprepitant 80 mg palonosetron 0.075 mg |
|
| aprepitant plus ramosetron | Active Comparator | aprepitant 80 mg ramosetron 0.3 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | aprepitant 80 mg is given to all patients before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Postoperative Nausea and Vomiting | The incidence of postoperative nausea and vomiting during 24 hours postoperatively | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant Plus Ramosetron | aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia |
| FG001 | Aprepitant Plus Palonosetron | aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant Plus Palonosetron | aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia |
| BG001 | Aprepitant Plus Ramosetron |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Postoperative Nausea and Vomiting | The incidence of postoperative nausea and vomiting during 24 hours postoperatively | Posted | Count of Participants | Participants | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aprepitant Plus Palonosetron | aprepitant 80 mg palonosetron 0.075 mg aprepitant: aprepitant 80 mg is given to all patients before surgery palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Younghoon Jeon | Kyungpook National University | 82534205871 | jeon68@gmail.com |
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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 |
|---|---|
| D000077608 | Aprepitant |
| D000077924 | Palonosetron |
| C071315 | ramosetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| palonosetron | Drug | palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia |
|
| Ramosetron | Drug | ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia |
|
aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Aprepitant Plus Ramosetron | aprepitant 80 mg ramosetron 0.3 mg aprepitant: aprepitant 80 mg is given to all patients before surgery Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia | 0 | 44 | 0 | 44 | 0 | 44 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D011812 |
| Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |