ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstetric Anesthesia Spinal Anesthesia Hypotension Fluid Therapy Cesarean Section

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydroxyethylstarch 130/0.4

Group Type EXPERIMENTAL

Hydroxyethylstarch 130/0.4

Intervention Type 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.

Interventions

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Hydroxyethylstarch 130/0.4

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.

Intervention Type DRUG

Other Intervention Names

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Voluven

Eligibility Criteria

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Inclusion Criteria

* Healthy pregnant women (ASA I or II)
* Normal pregnancy
* Term gestation (37 weeks and above)
* Elective cesarean section
* Spinal anesthesia

Exclusion Criteria

* Cardiopathies
* Hypertensive disease/ pre-eclampsia / eclampsia
* Any contraindication to neuraxial anesthesia
* Patient refusal
* Body mass index \> 30 at first antenatal visit and \> 32 at cesarean section
* Twin pregnancy
* Known allergies to HES
* Emergency cesarean section

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No