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During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.
Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.
In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.
The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine Intermittent Bolus | Active Comparator | Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution). |
|
| Phenylephrine Continuous Infusion | Active Comparator | Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum decrease in cardiac output in the pre-delivery period. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum decrease in heart rate in the pre-delivery period. | 30 minutes | |
| Incidence of hypotension in the pre-delivery period (BP < 80% baseline) | 30 minutes | |
| Incidence of hypertension in the pre-delivery period (BP > 120% baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Carvalho, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G1X5 | Canada |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 30 minutes |
| Incidence of nausea and vomiting in the pre-delivery period | 30 minutes |
| Total dose of phenylephrine in the pre-delivery period | 30 minutes |
| Umbilical artery and vein blood gases | 24 hours |
| D000588 |
| Amines |