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

Obstetric Anesthesia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Healthy pregnant women (ASA I or II) - Normal pregnancy - Term gestation (37 weeks and above) - Elective cesarean section - Spinal anesthesia Exclusion Criteria: - Cardiopathies - Hypertensive disease/ pre-eclampsia / eclampsia - Any contraindication to neuraxial anesthesia - Patient refusal - Body mass index > 30 at first antenatal visit and > 32 at cesarean section - Twin pregnancy - Known allergies to HES - Emergency cesarean section

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Obstetric Anesthesia

Spinal Anesthesia

Hypotension

Fluid Therapy

Cesarean Section

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Hydroxyethylstarch 130/0.4first 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hydroxyethylstarch 130/0.4

Study Status

Unknown status

Start Date: October 2011

Completed Date: June 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Volume of HES which will prevent hypotension if 50 % of the subjects.

Secondary Outcome: Incidence of hypotension episodes

Study sponsors, principal investigator, and references

Principal Investigator: Christian Loubert, MD, FRCPC

Lead Sponsor: Maisonneuve-Rosemont Hospital

Collaborator: Université de Montréal

More information:https://clinicaltrials.gov/show/NCT01415284

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