Clinical trial NCT00694343: Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Keywords: Cesarean section
spinal anesthesia
hypotension
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* elective cesarean section applying spinal anesthesia
* ≥ week 37 of gestation
* Singleton pregnancy

Exclusion Criteria:

* Suspicion of any hypertensive disease
* Parturient in labor

Primary outcomes:
measure: Incidence of hypotension
timeFrame: Time between induction of spinal anesthesia until delivery
Secondary outcomes:
measure: Minimum of systolic blood pressure until delivery
timeFrame: between induction of anesthesia and delivery
measure: Maternal heart rate between induction of anesthesia and delivery
timeFrame: between induction of anesthesia and delivery
measure: Onset and duration of hypotension between induction of anesthesia and delivery
timeFrame: between induction of anesthesia and delivery
measure: Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value
timeFrame: between induction of anesthesia and delivery
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
city: Colombes
country: France
facility: Höpital Louis-Mourier - Service d'Anesthesie
city: Le-Kremlin-Bicêtre
country: France
facility: Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
city: Lille
country: France
facility: Hopital Jeanne de Flandre, CHU
city: Lyon
country: France
facility: CHU Hotel Dieu, Service Anesthesie
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
city: Nice
country: France
facility: Hopital de l'Archet, Service Anesthesie-Reanimation
city: Nimes
country: France
facility: Hopital Caremeau, CHU, Service Anesthesie
city: Paris
country: France
facility: Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
city: Paris
country: France
facility: Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
city: Reims
country: France
facility: Hopital Robert Debre, CHU, Service Anesthesie
city: Strasbourg
country: France
facility: Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
city: Suresnes
country: France
facility: Hopital Foch,Service Anesthesie
city: Toulouse
country: France
facility: Unité d'anesthésie - Maternité Paule de Viguier
Study officials:
affiliation: Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France
name: Frederic Mercier, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
citation: Mercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aime M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 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. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.