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NCT Number: NCT01835873

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactated Ringer's

Other

HES 130/0.42

Other

Balanced colloid solution

Other names: Tetraspan® 6%

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Paraskevi Matsota

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Apr 19, 2013
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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