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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Fresenius Kabi

Current Primary Outcome: Incidence of hypotension [ Time Frame: Time between induction of spinal anesthesia until delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Minimum of systolic blood pressure until delivery [ Time Frame: between induction of anesthesia and delivery ]
  • Maternal heart rate between induction of anesthesia and delivery [ Time Frame: between induction of anesthesia and delivery ]
  • Onset and duration of hypotension between induction of anesthesia and delivery [ Time Frame: between induction of anesthesia and delivery ]
  • Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value [ Time Frame: between induction of anesthesia and delivery ]


Original Secondary Outcome: Same as current

Information By: Fresenius Kabi

Dates:
Date Received: June 6, 2008
Date Started: June 2008
Date Completion:
Last Updated: May 30, 2012
Last Verified: May 2012