We are studying healthy pregnant women undergoing planned caesarean section under spinal anaesthesia. We are investigating ways of reducing hypotension due to spinal anaesthesia by comparing 3 different phenylephrine infusion regimens. Phenylephrine is a drug routinely used in many obstetric anaesthesia centres to counteract hypotension.
Conditions
Interventions
Trade Name: Phenylephrine injection BP 10mg/ml
Product Name: Phenylephrine hydrochloride Ph Eur 1.0% w/v
Pharmaceutical Form: Solution for injection
Tr
Sponsors
Royal Free Hampstead NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant patients in good general health (ASA physical status 1 or 2) 2. Subject to be greater than 37 weeks gestation 3. Singleton uncomplicated pregnancy 4. Booked to deliver by elective caesarean section (Grade4) under spinal anaesthesia 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Circulatory disease 2. Cardiac disease / medications (e.g. beta blockers) 3. Pregnancy related disease (e.g. preeclampsia or pregnancy induced hypertension) 4. In active labour 5. Presenting for emergency caesarean section 6. Fetal abnormalities 7. Contraindications to spinal anaesthesia 8. Height greater than 180 cm or height less than 150 cm 9. Weight greater than 120 kg or weight less than 50 kg 10. Non-English speaking patients 11. Patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary endpoint will be to evaluate changes in cardiac output with these 3 phenylephrine infusion regimens. Cardiac output will be evaluated using a suprasternal Doppler cardiac output monitor. In this way we will determine which of the 3 regimens provides the most stable cardiovascular stability.;Secondary Objective: Secondary endpoints would be to evaluate changes in blood pressure and heart rate as well as fetal outcome in terms of umbilical cord blood gases.;Primary end point(s): Our primary endpoint will be to evaluate changes in cardiac output with these 3 phenylephrine infusion regimens. | — |
Countries
United Kingdom
Outcome results
None listed