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6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.
Br J Anaesth. 2014 Sep; 113(3):459-67.BJ

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+Show Affiliations

Département d'Anesthésie-Réanimation, Université Paris-Sud, APHP-Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France frederic.mercier@abc.aphp.fr.Département d'Anesthésie-Réanimation, Hôpital de Hautepierre, 67000 Strasbourg, France.Département d'Anesthésie-Réanimation, Hôpital Jeanne de Flandre, 59037 Lille, France.Département d'Anesthésie-Réanimation, APHP- Hôpital Cochin, 75014 Paris, France.Service d'Anesthésie-Réanimation, Hôpital Foch, 92150 Suresnes, France.Département d'Anesthésie-Réanimation, Hôpital Maison Blanche, 51100 Reims, France.Département d'Anesthésie-Réanimation, Hôpital Hotel Dieu, 69002 Clermont-Ferrand, France.Département d'Anesthésie-Réanimation, Hôpital Caremeau, 30000 Nîmes, France.Département d'Anesthésie-Réanimation, Hôpital de l'Archet, 06200 Nice, France.Département d'Anesthésie-Réanimation, Hôpital mère-enfant, 69500 Bron, France.Département d'Anesthésie-Réanimation, APHP-Hôpital Louis Mourier, 92701 Colombes, France.Département d'Anesthésie-Réanimation, APHP-Hôpital Armand-Trousseau, 75012 Paris, France.Département d'Anesthésie-Réanimation, Université Paris-Sud, APHP-Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24970272

Citation

Mercier, F J., et al. "6% Hydroxyethyl Starch (130/0.4) Vs Ringer's Lactate Preloading Before Spinal Anaesthesia for Caesarean Delivery: the Randomized, Double-blind, Multicentre CAESAR Trial." British Journal of Anaesthesia, vol. 113, no. 3, 2014, pp. 459-67.
Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, et al. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014;113(3):459-67.
Mercier, F. J., Diemunsch, P., Ducloy-Bouthors, A. S., Mignon, A., Fischler, M., Malinovsky, J. M., Bolandard, F., Aya, A. G., Raucoules-Aimé, M., Chassard, D., Keita, H., Rigouzzo, A., & Le Gouez, A. (2014). 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. British Journal of Anaesthesia, 113(3), 459-67. https://doi.org/10.1093/bja/aeu103
Mercier FJ, et al. 6% Hydroxyethyl Starch (130/0.4) Vs Ringer's Lactate Preloading Before Spinal Anaesthesia for Caesarean Delivery: the Randomized, Double-blind, Multicentre CAESAR Trial. Br J Anaesth. 2014;113(3):459-67. PubMed PMID: 24970272.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. AU - Mercier,F J, AU - Diemunsch,P, AU - Ducloy-Bouthors,A-S, AU - Mignon,A, AU - Fischler,M, AU - Malinovsky,J-M, AU - Bolandard,F, AU - Aya,A G, AU - Raucoules-Aimé,M, AU - Chassard,D, AU - Keita,H, AU - Rigouzzo,A, AU - Le Gouez,A, AU - ,, Y1 - 2014/06/26/ PY - 2014/6/28/entrez PY - 2014/6/28/pubmed PY - 2015/2/11/medline KW - Caesarean section KW - anaesthesia, spinal KW - fluid therapy, hydroxyethyl starch KW - fluid therapy, preloading KW - hypotension SP - 459 EP - 67 JF - British journal of anaesthesia JO - Br J Anaesth VL - 113 IS - 3 N2 - 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). SN - 1471-6771 UR - https://www.unboundmedicine.com/medline/citation/24970272/6_Hydroxyethyl_starch__130/0_4__vs_Ringer's_lactate_preloading_before_spinal_anaesthesia_for_Caesarean_delivery:_the_randomized_double_blind_multicentre_CAESAR_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(17)31770-1 DB - PRIME DP - Unbound Medicine ER -