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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia |
|
| 2 | Active Comparator | Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant + Dexamethasone | Drug | Aprepitant 40 mg + Dexamethasone 10 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Emesis | Any vomiting or retching | 48 h |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea | operative procedure | Post operative procedure (OP) hours (0-2, 24, 48) |
| Incidence of Vomiting (Post OP) | Post OP (0 - 2 hours) |
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Inclusion Criteria:
A patient is eligible for inclusion in this study if all of the following criteria apply:
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Habib, MBBCH, FRCA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21081776 | Result | Habib AS, Keifer JC, Borel CO, White WD, Gan TJ. A comparison of the combination of aprepitant and dexamethasone versus the combination of ondansetron and dexamethasone for the prevention of postoperative nausea and vomiting in patients undergoing craniotomy. Anesth Analg. 2011 Apr;112(4):813-8. doi: 10.1213/ANE.0b013e3181ff47e2. Epub 2010 Nov 16. |
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The study took place at Duke University Medical Center from September 2007 to June 2009, 146 signed the consent form, 115 were randomized, 104 completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant | Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia |
| FG001 | Ondansetron | Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant | Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia |
| BG001 | Ondansetron | Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia |
| 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 | Cumulative Incidence of Emesis | Any vomiting or retching | ITT analysis | Posted | Number | participants | 48 h |
|
|
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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 | Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashraf Habib | Duke University Medical Center | 9196686265 | habib001@mc.duke.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D003907 | Dexamethasone |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ondansetron + Dexamethasone |
| Drug |
Ondansetron 4 mg + Dexamethasone 10 mg |
|
| Incidence of Vomiting (24 Hours) | Any vomiting or retching | 24 h |
| Use of Rescue Antiemetics (Post OP) | Post OP (0 - 2 hours) |
| Use of Rescue Antiemetics (24 Hours) | 24 h |
| Use of Rescue Antiemetics (48 Hours) | 48 hour |
| Number of Participants With a Complete Response Rate | complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics. | 24 hours Post OP, 48 hours Post OP |
| Average Nausea Score | Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable | Post OP hours 0-2, 24 h, 48 h |
| Number of Vomiting Episodes | 48 hours |
| Time to First Vomiting | 48 h |
| Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied" | Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied) | 48 hour |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Secondary | Incidence of Nausea | operative procedure | Posted | Number | participants | Post operative procedure (OP) hours (0-2, 24, 48) |
|
|
|
| Secondary | Incidence of Vomiting (Post OP) | Posted | Number | participants | Post OP (0 - 2 hours) |
|
|
|
| Secondary | Incidence of Vomiting (24 Hours) | Any vomiting or retching | ITT analysis | Posted | Number | participants | 24 h |
|
|
|
| Secondary | Use of Rescue Antiemetics (Post OP) | Posted | Number | participants | Post OP (0 - 2 hours) |
|
|
|
| Secondary | Use of Rescue Antiemetics (24 Hours) | Posted | Number | participants | 24 h |
|
|
|
| Secondary | Use of Rescue Antiemetics (48 Hours) | Posted | Number | participants | 48 hour |
|
|
|
| Secondary | Number of Participants With a Complete Response Rate | complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics. | Posted | Number | participants | 24 hours Post OP, 48 hours Post OP |
|
|
|
| Secondary | Average Nausea Score | Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable | Posted | Mean | Inter-Quartile Range | units on a scale | Post OP hours 0-2, 24 h, 48 h |
|
|
|
| Secondary | Number of Vomiting Episodes | Posted | Mean | Inter-Quartile Range | vomiting episodes | 48 hours |
|
|
|
| Secondary | Time to First Vomiting | The analysis population only includes participants who had vomiting and had a complete data set | Posted | Median | Inter-Quartile Range | hours | 48 h |
|
|
|
| Secondary | Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied" | Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied) | Posted | Number | participants | 48 hour |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Ondansetron | Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia | 0 | 53 | 0 | 53 |
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| D012816 | Signs and Symptoms |
| D011246 |
| Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| 48 Hours Post Op |
|
| 48 hours post op |
|