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| Name | Class |
|---|---|
| Université de Montréal | OTHER |
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The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon & Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethylstarch 130/0.4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyethylstarch 130/0.4 | Drug | first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment. |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of HES which will prevent hypotension if 50 % of the subjects. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension episodes | 1 hour | |
| Incidence of hypertensive episodes | 1 hour | |
| cardiac output |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Loubert, MD, FRCPC | Contact | 514.252.3426 | loubertch@yahoo.fr | |
| Louis-Philippe Fortier, MD, FRCPC | Contact | 514.252.3426 | lpfortier@mac.com |
| Name | Affiliation | Role |
|---|---|---|
| Christian Loubert, MD, FRCPC | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maisonneuve-Rosemont Hospital | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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|
| 1 hour |
| Apgar score | 10 minutes |
| umbilical artery pH | 2 hours |
| additional vasopressors administered | 1 hour |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
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