Different Approaches to Maternal Hypotension During Cesarean Section
NCT ID: NCT00991627
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2009-09-30
2010-08-31
Brief Summary
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Detailed Description
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Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones.
According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation.
Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava.
The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pharmacological
Patients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values.
Bupivacaine
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 100 µg/ml solution, intrathecally
Lactated Ringer's solution
25 ml/min intravenously
Ephedrine, continuous infusion
37.5 mg/h intravenously
Ephedrine, bolus
6.25 mg IV bolus prn.
Hypotension defined according to study protocol for each arm.
Atropine
0.1 mg/kg iv bolus prn
Bradycardia defined as 50% drop in heart rate from baseline values.
Non-Pharmacological
Patients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values.
Bupivacaine
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 100 µg/ml solution, intrathecally
Lactated Ringer's solution
25 ml/min intravenously
Ephedrine, bolus
6.25 mg IV bolus prn.
Hypotension defined according to study protocol for each arm.
Atropine
0.1 mg/kg iv bolus prn
Bradycardia defined as 50% drop in heart rate from baseline values.
Interventions
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Bupivacaine
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Morphine
200 µg of a 100 µg/ml solution, intrathecally
Lactated Ringer's solution
25 ml/min intravenously
Ephedrine, continuous infusion
37.5 mg/h intravenously
Ephedrine, bolus
6.25 mg IV bolus prn.
Hypotension defined according to study protocol for each arm.
Atropine
0.1 mg/kg iv bolus prn
Bradycardia defined as 50% drop in heart rate from baseline values.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in ASA Physical Status Class I or II
* Informed written consent to participation
* Positive Supine Stress Test
Exclusion Criteria
* Indication to general anesthesia
* Known allergy to any of the study drugs
18 Years
50 Years
FEMALE
No
Sponsors
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Azienda Ospedaliero-Universitaria di Parma
OTHER
University of Parma
OTHER
Responsible Party
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UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Principal Investigators
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Guido Fanelli, MD
Role: STUDY_CHAIR
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Andrea Cornini, MD
Role: STUDY_DIRECTOR
UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Michele Zasa, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Locations
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University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy
Countries
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References
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Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.
Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.
Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4. doi: 10.1016/s0002-9378(96)70214-4.
Other Identifiers
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ANEST-OST-02
Identifier Type: -
Identifier Source: org_study_id
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