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

NCT ID: NCT01835873

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lactated Ringer's

Crystalloid solution - 1000 ml preload

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's

Intervention Type: OTHER

HES 130/0.42

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

Group Type: ACTIVE_COMPARATOR

HES 130/0.42

Intervention Type: OTHER

Balanced colloid solution

Interventions

Lactated Ringer's

Intervention Type: OTHER

HES 130/0.42

Balanced colloid solution

Intervention Type: OTHER

Other Intervention Names

Tetraspan® 6%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Paraskevi Matsota

OTHER

Sponsor Role: lead

Responsible Party

Paraskevi Matsota

Assistant Professor of Anesthesiology, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, Greece

Countries

Greece

Other Identifiers

492

Identifier Type: -

Identifier Source: org_study_id