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| Name | Class |
|---|---|
| Duke University | OTHER |
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Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine bolus | Experimental |
| |
| Phenylephrine infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine bolus | Drug | 10 ml of 100mcg/ml phenylephrine and placebo infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and Vomiting | intraoperative 2-3 hours | |
| Incidence of Nausea and Vomiting | 2 hrs postoperative | |
| Incidence of Nausea and Vomiting | 24hrs postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypotension | intraoperative - predelivery | |
| Incidence of Hypotension | intraoperative - postdelivery | |
| Neonatal Acidosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B George, MD FRCPC | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| IWK Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29209926 | Derived | George RB, McKeen DM, Dominguez JE, Allen TK, Doyle PA, Habib AS. A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women. Can J Anaesth. 2018 Mar;65(3):254-262. doi: 10.1007/s12630-017-1034-6. Epub 2017 Dec 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine Bolus | Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion |
| FG001 | Phenylephrine Infusion | phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine Bolus | Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion |
| BG001 | Phenylephrine Infusion | phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Nausea and Vomiting | Posted | Number | participants | intraoperative 2-3 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 | Phenylephrine Bolus | Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald B George | Department of Women's & Obstetric Anesthesia, IWK Health Centre | 902-470-6627 | rbgeorge@dal.ca |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| phenylephrine infusion |
| Drug |
60ml infusion of 100mcg/ml phenylephrine and placebo bolus |
|
| intraoperative |
| Halifax |
| Nova Scotia |
| B3H 6K8 |
| Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Incidence of Nausea and Vomiting | Posted | Number | participants | 2 hrs postoperative |
|
|
|
| Primary | Incidence of Nausea and Vomiting | Posted | Number | participants | 24hrs postoperative |
|
|
|
| Secondary | Incidence of Hypotension | Posted | Number | participants | intraoperative - predelivery |
|
|
|
| Secondary | Incidence of Hypotension | Posted | Number | participants | intraoperative - postdelivery |
|
|
|
| Secondary | Neonatal Acidosis | Posted | Mean | Standard Deviation | pH value | intraoperative |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Phenylephrine Infusion | phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus | 0 | 81 | 0 | 81 |
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| D013568 | Pathological Conditions, Signs and Symptoms |