Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

Study Overview
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Brief Summary
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The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

Detailed Description
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Intravenous fluid administration prior to spinal anesthesia for cesarean section is an established part of anesthetic practice for the prevention of maternal hypotension. Systematic reviews of clinical data suggest the usefulness of administering colloids to decrease the incidence of hypotension This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal anesthesia for elective cesarean section.

Official Title
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Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

Conditions
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Hypotension

Intervention / Treatment
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* Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion)
* Drug: Ringer's Lactate solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective cesarean section applying spinal anesthesia ≥ week 37 of gestation Singleton pregnancy Exclusion Criteria: Suspicion of any hypertensive disease Parturient in labor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution | Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion)<br>* 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution<br>* Other names: Voluven®;|
| Active Comparator: Group B<br>1000 mL Ringer's Lactate solution | Drug: Ringer's Lactate solution<br>* 1000 mL Ringer's Lactate solution<br>* Other names: Ringer's Lactate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension |  | Time between induction of spinal anesthesia until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum of systolic blood pressure until delivery |  | between induction of anesthesia and delivery | 
| Maternal heart rate between induction of anesthesia and delivery |  | between induction of anesthesia and delivery | 
| Onset and duration of hypotension between induction of anesthesia and delivery |  | between induction of anesthesia and delivery | 
| Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value |  | between induction of anesthesia and delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, spinal anesthesia, hypotension