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.
Conditions
Interventions
Trade Name: Phenylephrine Injection BP 10 mg/ml
Product Name: Phenylephrine Hydrochloride
Product Code: PL 06464/0902
Pharmaceutical Form: Solution for injection
Trade Name: Ephedrine Hydrochloride 3
Sponsors
Joint UCLH/UCH Biomedical Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 35 • Patient refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We would like to conduct a study to investigate whether, by maintaining a mother's normal systolic blood pressure with phenylephrine, as opposed to ephedrine after spinal anaesthesia for caesarean section, we can improve the heart muscle oxygen supply and demand ratio, and as a result see a difference in ECG changes between the 2 groups. ;Secondary Objective: For each following objective, we will compare the effect of ephedrine versus phenylephrine : We will examine the effect of ephedrine or phenylephrine on cardiac output (amount of blood pumped by the heart each minute) and heart rate. To monitor the cardiac output, we will use a non-invasive suprasternal doppler. This monitor uses an ultrasound probe, which will be placed on the skin just above the sternum. We will also compare the 2 vasopressors (ephedrine and phenylephrine) on the control of blood pressure by looking at incidence of low blood pressure episodes. At 24 hours post delivery, Troponin T will be measured to detect elevation which would indicate that ECG changes might be associated with lack of oxygen to the heart muscle. To compare neonatal outcomes (Agpar scores and umbilical cord gases) between each treatment group.;Primary end point(s): Occurence of ECG changes on Holter monitoring, yes or no. | — |
Countries
United Kingdom
Outcome results
None listed