ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

NCT01415284 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-02-15

No results posted yet for this study

Summary

The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.

Conditions

  • Obstetric Anesthesia
  • Spinal Anesthesia
  • Hypotension
  • Fluid Therapy
  • Cesarean Section

Interventions

DRUG

Hydroxyethylstarch 130/0.4

first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER
  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Christian Loubert, MD, FRCPC · Maisonneuve-Rosemont Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415284 on ClinicalTrials.gov