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
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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