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Significant challenges recruiting a difficult patient population with most surgeries occurring out of hours
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Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Active Comparator | Phenylephrine for maintaining blood pressure within 10 % of baseline |
|
| Ephedrine | Active Comparator | Ephedrine for maintaining blood pressure within 10 % of baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug |
| ||
| Ephedrine |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Tissue Oxygen Saturation | Intraoperative from spinal placement till 10 min after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | Intraoperative from spinal placement till 10 min after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Umbilical Cord Gases, pCO2 | Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord. | Within 5 minutes after delivery |
| Neonatal Umbilical Cord Gases, pH |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Habib, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine | Phenylephrine for maintaining blood pressure within 10 % of baseline Phenylephrine |
| FG001 | Ephedrine | Ephedrine for maintaining blood pressure within 10 % of baseline Ephedrine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine | Phenylephrine for maintaining blood pressure within 10 % of baseline Phenylephrine |
| BG001 | Ephedrine | Ephedrine for maintaining blood pressure within 10 % of baseline Ephedrine |
| 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 | Cerebral Tissue Oxygen Saturation | Posted | Mean | Standard Deviation | mmHg | Intraoperative from spinal placement till 10 min after delivery |
|
|
From admission to discharge (no more than a few days).
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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 | Phenylephrine for maintaining blood pressure within 10 % of baseline Phenylephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashraf Habib | Duke University, School of Medicine, Department of Anesthesiology | (919) 681-4544 | ashraf.habib@duke.edu |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D004809 | Ephedrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions.
| Within 5 minutes after delivery |
| Neonatal Umbilical Cord Gases, BE | The amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.) | Within 5 minutes after delivery |
| Number of Participants With Intraoperative Hypotension | Intraoperatively from spinal placement till 10 minutes after delivery |
| Number of Participants With Intraoperative Nausea | Intraoperatively from time of spinal placement until end of surgery |
| Number of Participants With Intraoperative Vomiting | Intraoperatively from time of spinal placement until end of surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| Gravida | The total number of confirmed pregnancies that a woman has had, regardless of the outcome. | Mean | Standard Deviation | pregnancies |
|
| Para | The number of births that a woman has had after 20 weeks gestation. | Mean | Standard Deviation | births |
|
|
|
|
| Secondary | Cardiac Output | Data for cardiac output from Physioflow worksheets was not available for two participants in the Phenylephrine group and all four participants in the Ephedrine group. | Posted | Mean | Standard Deviation | mL/minute | Intraoperative from spinal placement till 10 min after delivery |
|
|
|
| Other Pre-specified | Neonatal Umbilical Cord Gases, pCO2 | Partial pressure of carbon dioxide (pCO2) is the measure of carbon dioxide within arterial blood flowing through the umbilical cord. | Posted | Mean | Standard Deviation | mmHg | Within 5 minutes after delivery |
|
|
|
|
| Other Pre-specified | Neonatal Umbilical Cord Gases, pH | Used to assess acid-base balance. pH ranges from 0 to 14 and a pH of 7.40 is considered standard (normal) conditions. | Posted | Mean | Standard Deviation | unitless | Within 5 minutes after delivery |
|
|
|
|
| Other Pre-specified | Neonatal Umbilical Cord Gases, BE | The amount of strong acid (in mmol/L) that needs to be added in vitro to 1 liter of fully oxygenated blood in order to return the sample to standard (normal) conditions (pH 7.40, pCO2 40 mmHg and temperature 37 °C.) | Posted | Mean | Standard Deviation | mmol/L | Within 5 minutes after delivery |
|
|
|
|
| Other Pre-specified | Number of Participants With Intraoperative Hypotension | Posted | Count of Participants | Participants | Intraoperatively from spinal placement till 10 minutes after delivery |
|
|
|
|
| Other Pre-specified | Number of Participants With Intraoperative Nausea | Posted | Count of Participants | Participants | Intraoperatively from time of spinal placement until end of surgery |
|
|
|
|
| Other Pre-specified | Number of Participants With Intraoperative Vomiting | Posted | Count of Participants | Participants | Intraoperatively from time of spinal placement until end of surgery |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Ephedrine | Ephedrine for maintaining blood pressure within 10 % of baseline Ephedrine | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000588 |
| Amines |
| D011412 | Propanolamines |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |