Ephedrine vs Phenylephrine - ECG Changes
|ClinicalTrials.gov Identifier: NCT01243970|
Recruitment Status : Terminated (Change in clinical practice since the start of the trial in 2011 (phenylephrine superior))
First Posted : November 19, 2010
Last Update Posted : October 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Anesthesia Pregnancy||Drug: Phenylephrine Drug: Ephedrine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||April 2012|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
|Active Comparator: phenylephrine infusion||
Infusion dose 50 mcg / minute. On/off regimen in response to blood pressure (BP) readings every minute. Approximative 30 minutes treatment duration. Total dose 50 mcg - 1500 mcg *
* We will start the infusion after the spinal anaesthetic (see trial design), and while we will monitor cardiac output and BP (for 20 minutes) the surgeons will prep the patient (surgery not started yet). Birth should occur more or less 10-15 minutes after beginning surgery, so this is approximatively 30 minutes after spinal anaesthetic. It is very unlikely that the infusion will run continuously and exceed 1500 mcg.
|Active Comparator: Ephedrine infusion||
Infusion dose 4mg / minute. On/off regimen in response to blood pressure readings every minute. Approximative 30 minutes treatment duration. Total dose 4 mg - 120 mg. *
* We will start the infusion after the spinal anaesthetic(see trial design), and while we will monitor cardiac output and BP (for 20 minutes) the surgeons will prep the patient (surgery not started yet). Birth should occur more or less 10-15 minutes after beginning surgery, so this is approximatively 30 minutes after spinal anaesthetic. It is very unlikely that the infusion will run continuously and exceed 120mg.
- ST segment changes on Holter monitoring [ Time Frame: 30 minutes pre spinal anaesthesia to 4 hours post delivery ]
- Troponin levels [ Time Frame: 24h post delivery ]
- Incidence of maternal low systolic blood pressure [ Time Frame: 20 minutes post spinal and 30 minutes post delivery ]
- Maternal cardiac output [ Time Frame: 20 minutes post spinal and one measure at 5 minutes post delivery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243970
|University College London Hospital|
|London, United Kingdom, NW1 2BU|
|Principal Investigator:||Roshan Fernando, FRCA||University College London Hospital|