6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.

Abstract

BACKGROUND:

Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia (SA) for elective Caesarean delivery. We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch (HES) vs a Ringer's lactate (RL) preloading, when combined with a phenylephrine-based prophylaxis.

METHODS:

A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre, randomized, double-blind study. Patients received 500 ml of 6% HES (130/0.4)+500 ml of RL (HES group) or 1000 ml of RL (RL group) i.v. before SA. After SA, i.v. phenylephrine boluses were titrated when systolic arterial pressure (SAP) was below 95% of baseline. The primary outcome was the incidence of maternal hypotension (SAP <80% of baseline).

RESULTS:

The incidence of both hypotension and symptomatic hypotension (i.e. with dizziness, nausea/vomiting, or both) was significantly lower in the HES group vs the RL group: 36.6% vs 55.3% (one-sided P=0.025) and 3.7% vs 14.1%. There was no significant difference in total phenylephrine requirements [median (range): 350 (50-1800) vs 350 (50-1250) µg]. The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [1.2 (1.0) vs 1.0 (0.9) g dl(-1)]. There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group. Neonatal outcomes were comparable between the groups.

CONCLUSIONS:

Compared with a pure RL preloading, a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects.

CLINICAL TRIAL REGISTRATION:

NCT00694343 (http://clinicaltrials.gov).

• Authors: F J Mercier, P Diemunsch, A-S Ducloy-Bouthors, A Mignon, M Fischler, J-M Malinovsky, F Bolandard, A G Aya, M Raucoules-Aimé, D Chassard, H Keita, A Rigouzzo, A Le Gouez, CAESAR Working Group
• Journal: British journal of anaesthesia (Br J Anaesth) Vol. 113 Issue 3 Pg. 459-67 (Sep 2014) ISSN: 1471-6771 [Electronic] England
• PMID: 24970272 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author [2014]. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Hydroxyethyl Starch Derivatives
• Isotonic Solutions
• Plasma Substitutes
• Ringer's Lactate
• Vasoconstrictor Agents
• Phenylephrine

Topics

• Adult
• Anesthesia, Obstetrical (adverse effects, methods)
• Anesthesia, Spinal (adverse effects, methods)
• Blood Pressure (drug effects)
• Cesarean Section (methods)
• Double-Blind Method
• Female
• Humans
• Hydroxyethyl Starch Derivatives (administration & dosage)
• Hypotension (chemically induced, prevention & control)
• Isotonic Solutions (administration & dosage)
• Middle Aged
• Phenylephrine (therapeutic use)
• Plasma Substitutes (therapeutic use)
• Preanesthetic Medication (methods)
• Ringer's Lactate
• Treatment Outcome
• Vasoconstrictor Agents (therapeutic use)
• Young Adult