Hypotension Clinical Trial
Official title:
Comparative Study of the Effect of 6% Hydroxyethyl Starch 130/0.42 vs Lactated Ringer's Preload on the Hemodynamic Status of Parturients Undergoing Spinal Anesthesia for Elective Cesarean Delivery. Arterial Pulse Contour Analysis (FloTrac/VigileoTM) is Employed for Continuous Monitoring of Maternal Hemodynamic Parameters
NCT number | NCT01835873 |
Other study ID # | 492 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | April 6, 2013 |
Last updated | July 12, 2013 |
Start date | March 2011 |
Verified date | July 2013 |
Source | Attikon Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia
obstetric deliveries because of the ability to use fewer drugs, a more direct experience of
childbirth and the capability to provide excellent postoperative analgesia. However, the
incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead
to maternal and fetal morbidities. Certain interventions may reduce the incidence and
severity of spinal anesthesia induced hypotension, including the use of vasopressors and
intravenous pre- or co-hydration using different types of volume expanders; crystalloid or
colloid solutions. Such interventions aim to increase maternal cardiac output, which is the
key in attenuating the hypotensive response to spinal anesthesia.
The primary purpose of this study is to compare the efficacy of intravenous prehydration
(preloading) of healthy parturients scheduled for caesarean section with either a
crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of
hypotension after spinal anesthesia.
The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by
employment of a minimally invasive technique based on arterial pulse contour analysis.
Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a
secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal
outcome, intraoperative side effects and maternal satisfaction scores.
Status | Completed |
Enrollment | 32 |
Est. completion date | |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists (ASA) I and II parturients - singleton gestation - term gestation (gestational period more than 37 weeks) Exclusion Criteria: - extremes of weight (<50 Kgr or >120 Kgr) - extremes of height (<150 cm or >180 cm) - baseline heart rate less than 65 bpm - active labor - known fetal abnormalities - placental abruption, placenta previa/accreta - pregnancy induced hypertension - anemia (hemoglobin < 9 gr/dl) - cardiac, respiratory or renal disease - diabetes mellitus - spinal cord abnormalities - previous spinal surgery - preexisting neurological dysfunction - known allergy to any protocol medication - any absolute contraindication to regional anesthesia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Department of Anesthesiology, Attikon University Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Paraskevi Matsota |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution. | Maternal hemodynamic data is assessed before volume preload, immediately after volume preload, immediately after spinal anesthesia and at one minute intervals thereafter until placental delivery. Expected average of 40 minutes. | No |
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