ow dose of ephedrine versus phenylephrine in the prevention of arterial hypotension after low dosed CSE for elective C-section : is there a difference in umbilical blood gas values ?
Phase 1
- Conditions
- combined spinal-epidural analgesia during C-section
- Registration Number
- EUCTR2007-003926-11-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- ASA I and II
- singleton pregnancy
- > 36 weeks gestational stage
- elective C-section
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- ASA III and IV
- (pre)eclampsia
- intake of anti-hypertensive medication
- contra-indication for loco-regional anesthesia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate if there is a significant difference between the umbilical blood gas levelsbetweeen subjects who received ephedrine as phrophylactic treatment for postspinal hypotension and subjects whe received phenylephrin.;Secondary Objective: - incidence of arterial hypotension<br>- incidence of bradycardia and tachycardia;Primary end point(s): Has the administrion of a low, prophylactic dose of ephedrine an influence on the umbilical arterial pH ?
- Secondary Outcome Measures
Name Time Method