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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01415284
• Other study ID #: LoubertHMR2011/01
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: February 12, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2013
• Source: Maisonneuve-Rosemont Hospital
• Contact: Christian Loubert, MD, FRCPC
• Phone: 514.252.3426
• Email: loubertch[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).

Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon & Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of HES which will prevent hypotension if 50 % of the subjects.		4 months	No
Secondary	Incidence of hypotension episodes		1 hour	No
Secondary	Incidence of hypertensive episodes		1 hour	No
Secondary	cardiac output		1 hour	No
Secondary	Apgar score		10 minutes	No
Secondary	umbilical artery pH		2 hours	No
Secondary	additional vasopressors administered		1 hour	No