NCT00694343

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DRUG	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
DRUG	Ringer's Lactate solution	1000 mL Ringer's Lactate solution

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2008-06-10
• Last updated: 2012-05-31

Locations

14 sites across 1 country: France