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Ephedrine vs Phenylephrine - ECG Changes

This study has been terminated.
(Change in clinical practice since the start of the trial in 2011 (phenylephrine superior))
Sponsor:
Collaborator:
Obstetric Anaesthetists' Association
Information provided by (Responsible Party):
Roshan Fernando, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT01243970
First received: November 18, 2010
Last updated: October 25, 2016
Last verified: October 2016

November 18, 2010
October 25, 2016
April 2012
January 2016   (final data collection date for primary outcome measure)
ST segment changes on Holter monitoring [ Time Frame: 30 minutes pre spinal anaesthesia to 4 hours post delivery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01243970 on ClinicalTrials.gov Archive Site
  • Troponin levels [ Time Frame: 24h post delivery ] [ Designated as safety issue: No ]
  • Incidence of maternal low systolic blood pressure [ Time Frame: 20 minutes post spinal and 30 minutes post delivery ] [ Designated as safety issue: No ]
  • Maternal cardiac output [ Time Frame: 20 minutes post spinal and one measure at 5 minutes post delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ephedrine vs Phenylephrine - ECG Changes
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Anesthesia
  • Pregnancy
  • Drug: Phenylephrine

    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.

  • Drug: Ephedrine

    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.

  • Active Comparator: phenylephrine infusion
    Intervention: Drug: Phenylephrine
  • Active Comparator: Ephedrine infusion
    Intervention: Drug: Ephedrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01243970
08/0182
Yes
Not Provided
Not Provided
Roshan Fernando, University College London Hospitals
University College London Hospitals
Obstetric Anaesthetists' Association
Principal Investigator: Roshan Fernando, FRCA University College London Hospital
University College London Hospitals
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP