title: 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.
  
  
  BACKGROUND
  NCT00694343 (http://clinicaltrials.gov).
authors: 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.
authors: F J
authors: FJ
authors: Mercier
authors: Département d'Anesthésie-Réanimation, Hôpital de Hautepierre, 67000 Strasbourg, France.
authors: P
authors: P
authors: Diemunsch
authors: Département d'Anesthésie-Réanimation, Hôpital Jeanne de Flandre, 59037 Lille, France.
authors: A-S
authors: AS
authors: Ducloy-Bouthors
authors: Département d'Anesthésie-Réanimation, APHP- Hôpital Cochin, 75014 Paris, France.
authors: A
authors: A
authors: Mignon
authors: Service d'Anesthésie-Réanimation, Hôpital Foch, 92150 Suresnes, France.
authors: M
authors: M
authors: Fischler
authors: Département d'Anesthésie-Réanimation, Hôpital Maison Blanche, 51100 Reims, France.
authors: J-M
authors: JM
authors: Malinovsky
authors: Département d'Anesthésie-Réanimation, Hôpital Hotel Dieu, 69002 Clermont-Ferrand, France.
authors: F
authors: F
authors: Bolandard
authors: Département d'Anesthésie-Réanimation, Hôpital Caremeau, 30000 Nîmes, France.
authors: A G
authors: AG
authors: Aya
authors: Département d'Anesthésie-Réanimation, Hôpital de l'Archet, 06200 Nice, France.
authors: M
authors: M
authors: Raucoules-Aimé
authors: Département d'Anesthésie-Réanimation, Hôpital mère-enfant, 69500 Bron, France.
authors: D
authors: D
authors: Chassard
authors: Département d'Anesthésie-Réanimation, APHP-Hôpital Louis Mourier, 92701 Colombes, France.
authors: H
authors: H
authors: Keita
authors: Département d'Anesthésie-Réanimation, APHP-Hôpital Armand-Trousseau, 75012 Paris, France.
authors: A
authors: A
authors: Rigouzzo
authors: Département d'Anesthésie-Réanimation, Université Paris-Sud, APHP-Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France.
authors: A
authors: A
authors: Le Gouez
mesh_terms: D000328:Adult; D000773:Anesthesia, Obstetrical / Q000009:adverse effects / Q000379:methods*; D000775:Anesthesia, Spinal / Q000009:adverse effects / Q000379:methods*; D001794:Blood Pressure / Q000187:drug effects; D002585:Cesarean Section / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage*; D007022:Hypotension / Q000139:chemically induced / Q000517:prevention & control*; D007552:Isotonic Solutions / Q000008:administration & dosage*; D008875:Middle Aged; D010656:Phenylephrine / Q000627:therapeutic use; D010952:Plasma Substitutes / Q000627:therapeutic use; D011229:Preanesthetic Medication / Q000379:methods*; D000077325:Ringer's Lactate; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D007552:Isotonic Solutions; D010952:Plasma Substitutes; D000077325:Ringer's Lactate; D014662:Vasoconstrictor Agents; D010656:Phenylephrine
keywords: Caesarean section; anaesthesia, spinal; fluid therapy, hydroxyethyl starch; fluid therapy, preloading; hypotension