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| ID | Type | Description | Link |
|---|---|---|---|
| Duke-12142 |
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| Name | Class |
|---|---|
| IWK Health Centre | OTHER |
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The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide | Active Comparator | Prophylaxis with metoclopramide and phenylephrine infusion. |
|
| Phenylephrine infusion | Placebo Comparator | Prophylactic phenylephrine infusion and placebo antiemetics |
|
| Combination Group | Active Comparator | Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Nausea and Vomiting | Comparison of intraoperative nausea and vomiting between the 3 groups. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) | 0-2h, 2-6h, 6-24h | |
| Pruritus | 0-24 hrs | |
| Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
Laboring women needing an emergency cesarean delivery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23635626 | Derived | Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee. |
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December 2008-January 2011, University Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Group | Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis |
| FG001 | Metoclopramide | Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal |
| FG002 | Phenylephrine Infusion | Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Group | Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis |
| BG001 | Metoclopramide | Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal |
| 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 | Intraoperative Nausea and Vomiting | Comparison of intraoperative nausea and vomiting between the 3 groups. | Posted | Number | participants | Intraoperatively |
|
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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 | Combination Group | Metoclopramide and Ondansetron prophylaxis Combination Group : Metoclopramide and ondansetron prophylaxis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashraf Habib | Duke University Medical Center | 919 668 6266 | habib001@dm.duke.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Phenylephrine infusion | Drug | Prophylactic phenylephrine infusion after spinal and placebo antiemetics |
|
| Combination Group | Drug | Metoclopramide and ondansetron prophylaxis with phenylephrine infusion |
|
|
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
| 24 h |
| Maternal Hemodynamics | The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively | Intraoperatively |
| BG002 | Phenylephrine Infusion | Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Postoperative Nausea and Vomiting (PONV) | Posted | Number | participants | 0-2h, 2-6h, 6-24h |
|
|
|
| Secondary | Pruritus | Posted | Number | participants | 0-24 hrs |
|
|
|
| Secondary | Satisfaction | 1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted. | Posted | Number | participants | 24 h |
|
|
|
| Secondary | Maternal Hemodynamics | The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively | Posted | Number | participants with SBP< 20 % baseline | Intraoperatively |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Metoclopramide | Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal | 0 | 99 | 0 | 99 |
| EG002 | Phenylephrine Infusion | Prophylactic phenylephrine infusion and placebo antiemetics Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal | 0 | 100 | 0 | 100 |
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| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Title | Measurements |
|---|---|
|
| 6-24 hrs PONV |
|