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A comparison of speed of action of phenylephrine and ephedrine
ISRCTN ISRCTN42749317
DOI 10.1186/ISRCTN42749317
ClinicalTrials.gov identifier
EudraCT number
Public title A comparison of speed of action of phenylephrine and ephedrine
Scientific title
Acronym N/A
Serial number at source N0521113691
Study hypothesis Does phenylephrine allow more rapid control of maternal arterial pressure during obstetric spinal anaesthesia than ephedrine?
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised doubleblind controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pregnancy and Childbirth: Anaesthesia
Participants - inclusion criteria Healthy women having elective caesarean section at term will be recruited.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 27/03/2002
Anticipated end date 30/06/2004
Status of trial Completed
Patient information material
Target number of participants No data is available to guide sample size estimations.
Interventions Phenylephrine vs ephedrine

A standardised anaesthetic technique will be used. Maternal arterial pressure will be measured by an automated oscillometric device (Cardiocap II, Datex Instrumentarium) and by a continuous, non-invasive photoplethysmographic device using a finger probe (Finapres 2300, Ohmeda). Boluses of phenylephrine 100 ug or ephedrine 6 mg will be given whenever systolic arterial pressure falls by 15% from the prespinal value. An analog arterial pressure waveform will be recorded using a PowerLab 8sp recording and analysis device (AD Instruments Inc). This time from administration of vasopressor to time of peak effect on arterial pressure will then be analysed.
Primary outcome measure(s) Ttime to peak vasopressor effect on systolic arterial pressure
Secondary outcome measure(s) Not provided at time of registration
Sources of funding County Durham and Darlington Acute Hospitals NHS Trust (North) (UK)
Trial website
Publications
Contact name Dr  D  Thomas
  Address University Hospital of North Durham
North Road
  City/town Durham
  Zip/Postcode DH1 5TW
  Country United Kingdom
  Tel +44 (0)191 333 2360
  Email
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 01/11/2011
Date ISRCTN assigned 30/09/2004
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