Prophylactic ephedrine and hypotension during spinal anaesthesia for elective Caesarean section

ISRCTN	ISRCTN26979860
DOI	https://doi.org/10.1186/ISRCTN26979860
Secondary identifying numbers	N0187122160

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ian Taylor
Scientific

Anaesthetics Department
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Phone	+44 (0)23 9228 6000

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Anaesthesia
Intervention	1. Ephedrine infusion 2. Ephedrine bolus 3. Saline
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	18/11/2002
Completion date	30/06/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	105
Key inclusion criteria	A total of 105 patients (35 per group) age >16 years.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	18/11/2002
Date of final enrolment	30/06/2003

Anaesthetics Department

Portsmouth
PO6 3LY
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Portsmouth NHS Research and Development Consortium (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan