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The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Lactated Ringer's
HES 130/0.42
Sponsored by
Paraskevi Matsota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • 2nd Department of Anesthesiology, Attikon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lactated Ringer's

HES 130/0.42

Arm Description

Crystalloid solution - 1000 ml preload

Hydroxyethyl starch (HES 130/0.42) - 500 ml preload

Outcomes

Primary Outcome Measures

Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2013
Last Updated
July 12, 2013
Sponsor
Paraskevi Matsota
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1. Study Identification

Unique Protocol Identification Number
NCT01835873
Brief Title
The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paraskevi Matsota

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactated Ringer's
Arm Type
Active Comparator
Arm Description
Crystalloid solution - 1000 ml preload
Arm Title
HES 130/0.42
Arm Type
Active Comparator
Arm Description
Hydroxyethyl starch (HES 130/0.42) - 500 ml preload
Intervention Type
Other
Intervention Name(s)
Lactated Ringer's
Intervention Type
Other
Intervention Name(s)
HES 130/0.42
Other Intervention Name(s)
Tetraspan® 6%
Intervention Description
Balanced colloid solution
Primary Outcome Measure Information:
Title
Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution.
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon University Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece

12. IPD Sharing Statement

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The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery

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