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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694343

Acronym

CAESAR

Enrollment

167

Registered

2008-06-10

Start date

2008-06-30

Completion date

2010-06-30

Last updated

2012-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Cesarean section, spinal anesthesia, hypotension

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.

Interventions

DRUGHES 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

DRUGRinger's Lactate solution

1000 mL Ringer's Lactate solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of hypotension	Time between induction of spinal anesthesia until delivery

Secondary

Measure	Time frame
Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value	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
Minimum of systolic blood pressure until delivery	between induction of anesthesia and delivery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026