Randomised, double blind, phase IV study to compare the incidence of ECG changes during elective caesarean section under spinal anaesthesia when using phenylephrine or ephedrine infusion to maintain baseline systolic blood pressure - Ephedrine vs phenylephrine – ECG changes. V1
- Conditions
- uncomplicated term pregnancy. Patient undergoing elective cesarean delivery. Ephedrine and phenylephrine are vasopressors used to maintain maternal blood pressure close to normal values during spinal anaesthesia.
- Registration Number
- EUCTR2009-013293-41-GB
- Lead Sponsor
- Joint UCLH/UCH Biomedical Research Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 220
Inclusion Criteria:
• >37/40 weeks gestation
• Singleton pregnancy
• Elective caesarean section under spinal anaesthesia
• In good general health (American Society of Anesthesiologists health status category 1 or 2)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria:
•Circulatory disease (eg pre-existing hypertension)
•Cardiac disease/medications (eg.angina, cardiomyopathy, B Blocker
medication)
•Pregnancy related disease (pre-eclampsia)
. Diabetes that pre-exists the pregnancy
. Renal disease
. Hyperthyroidism
. Closed angle glaucoma
•In active labour
•Emergency caesarean section
•Fetal abnormalities
•Contraindications to spinal anaesthesia
•Height >6 feet/180cm / Height <5 feet/150cm
•BMI <19 or >35
•Patient refusal to participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method