Different Approaches to Maternal Hypotension During Cesarean Section

Summary

The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.

Conditions

• Pregnancy
• Cesarean Section
• Anesthesia,Spinal
• Hypotension

Interventions

DRUG

Bupivacaine

10 mg of a 5 mg/ml hyperbaric solution, intrathecally

DRUG

Morphine

200 µg of a 100 µg/ml solution, intrathecally

DRUG

Lactated Ringer's solution

25 ml/min intravenously

DRUG

Ephedrine, continuous infusion

37.5 mg/h intravenously

DRUG

Ephedrine, bolus

6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.

DRUG

Atropine

0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• University of Parma

  lead OTHER

Principal Investigators

• Guido Fanelli, MD · Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

• Andrea Cornini, MD · UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma

• Michele Zasa, MD · Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2010-08-31

Completion

2010-08-31

Countries

• Italy

Study Locations