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

NCT01835873 | Completed

• 1 other identifier: 492
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Lactated Ringer's

ACTIVE COMPARATOR

Crystalloid solution - 1000 ml preload

Other: Lactated Ringer's

HES 130/0.42

ACTIVE COMPARATOR

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

Other: HES 130/0.42

Interventions

Lactated Ringer's OTHER

Lactated Ringer's

HES 130/0.42 OTHER

Balanced colloid solution

Also known as: Tetraspan® 6%

HES 130/0.42

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) I and II parturients
• singleton gestation
• term gestation (gestational period more than 37 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Paraskevi Matsota: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Hypotension

Interventions

Ringer's Lactate; HES 130-0.42-6:1

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, MD, PhD

Study Record Dates

• First Submitted: April 6, 2013
• First Posted: April 19, 2013
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

GR (1)