F J Mercier1, P Diemunsch2, A-S Ducloy-Bouthors3, A Mignon4, M Fischler5, J-M Malinovsky6, F Bolandard7, A G Aya8, M Raucoules-Aimé9, D Chassard10, H Keita11, A Rigouzzo12, A Le Gouez13. 1. 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. 2. Département d'Anesthésie-Réanimation, Hôpital de Hautepierre, 67000 Strasbourg, France. 3. Département d'Anesthésie-Réanimation, Hôpital Jeanne de Flandre, 59037 Lille, France. 4. Département d'Anesthésie-Réanimation, APHP- Hôpital Cochin, 75014 Paris, France. 5. Service d'Anesthésie-Réanimation, Hôpital Foch, 92150 Suresnes, France. 6. Département d'Anesthésie-Réanimation, Hôpital Maison Blanche, 51100 Reims, France. 7. Département d'Anesthésie-Réanimation, Hôpital Hotel Dieu, 69002 Clermont-Ferrand, France. 8. Département d'Anesthésie-Réanimation, Hôpital Caremeau, 30000 Nîmes, France. 9. Département d'Anesthésie-Réanimation, Hôpital de l'Archet, 06200 Nice, France. 10. Département d'Anesthésie-Réanimation, Hôpital mère-enfant, 69500 Bron, France. 11. Département d'Anesthésie-Réanimation, APHP-Hôpital Louis Mourier, 92701 Colombes, France. 12. Département d'Anesthésie-Réanimation, APHP-Hôpital Armand-Trousseau, 75012 Paris, France. 13. Département d'Anesthésie-Réanimation, Université Paris-Sud, APHP-Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France.
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).
RCT Entities:
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: Cheryl Chooi; Julia J Cox; Richard S Lumb; Philippa Middleton; Mark Chemali; Richard S Emmett; Scott W Simmons; Allan M Cyna Journal: Cochrane Database Syst Rev Date: 2020-07-01