Status:

UNKNOWN

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

Lead Sponsor:

Maisonneuve-Rosemont Hospital

Collaborating Sponsors:

Université de Montréal

Conditions:

Obstetric Anesthesia

Spinal Anesthesia

Eligibility:

FEMALE

Phase:

PHASE4

Brief 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 ces...

Detailed Description

The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower th...

Eligibility Criteria

Inclusion

  • Healthy pregnant women (ASA I or II)
  • Normal pregnancy
  • Term gestation (37 weeks and above)
  • Elective cesarean section
  • Spinal anesthesia

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2013

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01415284

Start Date

October 1 2011

End Date

June 1 2013

Last Update

February 15 2013

Active Locations (1)

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1

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada, H1T 2M4

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