Clinical trial NCT01243970: Ephedrine vs Phenylephrine - ECG Changes
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Spinal Anesthesia
Pregnancy
Keywords: Spinal anaesthesia
phenylephrine
ephedrine
ECG changes
Caesarean delivery
Myocardial ischaemia
Cardiac output
hypotension
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: Obstetric Anaesthetists' Association United Kingdom
First posted: 2010-11-19
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ECG changes during caesarean section are common. Incidence of ST depression on the ECG is up to 81% in some studies. Although this may indicate inadequate oxygen supply to the heart muscle (myocardial ischaemia) many other theories have been suggested including air entering the circulation from the placental bed, high heart rate, hormone or nervous system influences and spasm of the coronary blood supply. Perioperative ST depression often reflects an imbalance between heart muscle oxygen supply and demand. At the time of delivery, high heart rate is common and there is a further increase in the amount of blood the heart has to pump every minute due to blood coming back to the circulation from the placental bed. This increases oxygen demand and most ST changes are seen at the time of delivery or within 30 minutes. The clinical significance of these changes is much debated, and apart from a few case reports do not appear to be associated with poor heart muscle function or ischaemia (lack of oxygen supply). Management of the mother's blood pressure during caesarean section has changed greatly in recent years. Intermittent boluses of ephedrine, given when blood pressure is low, have been replaced with prevention of low blood pressure and phenylephrine has become the drug of choice. Ephedrine increases heart rate and contractility of the heart muscle and is likely to increase oxygen demand. Phenylephrine reduces heart rate while maintaining blood pressure which may result in a more favorable oxygen supply demand ratio.

The investigators aim to compare the incidence of ECG changes if the mother's blood pressure is maintained with phenylephrine as compared to ephedrine. To see if these ECG changes are associated with myocardial ischaemia, the investigators will perform troponin T analysis after delivery. Troponin T is a molecule released by ischaemic heart muscle.


Eligibility criteria: Inclusion Criteria:

1. Able to give written informed consent
2. \>37/40 weeks gestation
3. Singleton pregnancy
4. Elective caesarean section under spinal anaesthesia
5. In good general health (American Society of Anesthesiology Category 1 or 2, fit and well or with mild systemic disease that has no impact on physical activity )

Exclusion Criteria:

1. Circulatory disease (eg pre-existing hypertension)
2. Cardiac disease/medications (e.g. angina, cardiomyopathy, B Blocker medication)
3. Pregnancy related disease (eg pre-eclampsia)
4. Diabetes pre-existing the pregnancy
5. Hyperthyroidism
6. Renal Disease
7. Closed-angle glaucoma
8. Patients on monoamine oxidase inhibitors
9. In active labour
10. Emergency caesarean section
11. Fetal abnormalities
12. Contraindications to spinal anaesthesia
13. Height \>6 feet/180cm / Height \<5 feet/150cm
14. Body mass index (BMI) \<19 or \>35

Primary outcomes:
measure: ST segment changes on Holter monitoring
timeFrame: 30 minutes pre spinal anaesthesia to 4 hours post delivery
Secondary outcomes:
measure: Troponin levels
timeFrame: 24h post delivery
measure: Incidence of maternal low systolic blood pressure
timeFrame: 20 minutes post spinal and 30 minutes post delivery
measure: Maternal cardiac output
timeFrame: 20 minutes post spinal and one measure at 5 minutes post delivery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College London Hospital
name: Roshan Fernando, FRCA
role: PRINCIPAL_INVESTIGATOR
References: