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

Phase 4

Completed

• Conditions: Hypotension
• Interventions: Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion); Drug: Ringer's Lactate solution

• Registration Number: NCT00694343
• Lead Sponsor: Fresenius Kabi

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 167

Inclusion Criteria

• elective cesarean section applying spinal anesthesia
• ≥ week 37 of gestation
• Singleton pregnancy

Exclusion Criteria

• Suspicion of any hypertensive disease
• Parturient in labor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HES 130/0.4 (6%) in sodium chloride (solution for infusion)	500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
Group B	Ringer's Lactate solution	1000 mL Ringer's Lactate solution

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	Time between induction of spinal anesthesia until delivery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

CHU Hotel Dieu, Service Anesthesie; 🇫🇷 Lyon, France

Höpital Louis-Mourier - Service d'Anesthesie; 🇫🇷 Colombes, France

CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation; 🇫🇷 Clermont Ferrand, France

Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre; 🇫🇷 Le-Kremlin-Bicêtre, France

Hopital Jeanne de Flandre, CHU; 🇫🇷 Lille, France

Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation; 🇫🇷 Montpellier, France

Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale; 🇫🇷 Paris, France

Hopital de l'Archet, Service Anesthesie-Reanimation; 🇫🇷 Nice, France

Hôpital Armand-Trousseau, Service d'anesthésie-réanimation; 🇫🇷 Paris, France

Hopital Caremeau, CHU, Service Anesthesie; 🇫🇷 Nimes, France

Hopital Robert Debre, CHU, Service Anesthesie; 🇫🇷 Reims, France

Hopital Hautepierre, CHU, Service Reanimation Chirurgicale; 🇫🇷 Strasbourg, France

Hopital Foch,Service Anesthesie; 🇫🇷 Suresnes, France

Unité d'anesthésie - Maternité Paule de Viguier; 🇫🇷 Toulouse, France