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Results Invalid, study closed, analysis cannot proceed.
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This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min.
The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine infusion | Drug | Up-down, biased coin design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension | The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min. | Spinal administration until delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Six subjects were withdrawn from the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine Infusion | Phenylephrine infusion : Up-down, biased coin design |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine Infusion | Phenylephrine infusion : Up-down, biased coin design |
| 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 | Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension | The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min. | Posted | Number | dose of phenylephrine | Spinal administration until delivery |
|
|
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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 Infusion | Phenylephrine infusion : Up-down, biased coin design |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ron George | IWK Health Centre | 470-6627 | rbgeorge@dal.ca |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
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