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

Fresenius Kabi

Status and phase: Completed; Phase 4

Conditions: Hypotension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694343

07-HE06-03

EudraCT no.:2007-006065-32

Details and patient eligibility

About

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

Full 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.

Enrollment: 167 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Suspicion of any hypertensive disease
• Parturient in labor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 2 patient groups

Group A

Experimental group

Description:

500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution

Treatment:

Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion)

Group B

Active Comparator group

Description:

1000 mL Ringer's Lactate solution

Treatment:

Drug: Ringer's Lactate solution