Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0187122160
Study information
Scientific title
Acronym
Study hypothesis
The majority of elective Caesarean section operations are performed using a spinal anaesthetic. One of the common problems with this technique is a fall in the patient's blood pressure - occurring in approximately 70% of cases. At present we closely monitor blood pressure and treat any fall with fluids and/or intravenous drugs (usually ephedrine) as it occurs.
The aim of this study is to assess whether or not the frequency of a fall in blood pressure can actually be avoided by the use of ephedrine before a drop occurs. Secondly, if prophylactic ephedrine is of benefit we hope to find out which is the best way to administer the drug: either by a bolus or by a continuous infusion.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and Childbirth: Anaesthesia
Intervention
1. Ephedrine infusion
2. Ephedrine bolus
3. Saline
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/11/2002
Overall trial end date
30/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
A total of 105 patients (35 per group) age >16 years.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
105
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
18/11/2002
Recruitment end date
30/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics Department
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Portsmouth NHS Research and Development Consortium (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