Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0521113691
Study information
Scientific title
A comparison of speed of action of phenylephrine and ephedrine
Acronym
Study hypothesis
Does phenylephrine allow more rapid control of maternal arterial pressure during obstetric spinal anaesthesia than ephedrine?
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy and Childbirth: Anaesthesia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Phenylephrine and ephedrine
Primary outcome measures
Ttime to peak vasopressor effect on systolic arterial pressure
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/03/2002
Overall trial end date
30/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy women having elective caesarean section at term will be recruited.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
No data is available to guide sample size estimations.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/03/2002
Recruitment end date
30/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of North Durham
Durham
DH1 5TW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
County Durham and Darlington Acute Hospitals NHS Trust (North) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary