Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0016176701
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of two vasopressors (drugs that are used to prevent blood pressure falling-hypotension- after spinal anaesthesia) on the dosages of local anaesthetic required to provide successful anaesthesia for caesarean section (CS).
As of 28/07/09 this record was updated. All updates can be found under the relevant field with the above update date.
Ethics approval
Added as of 28/07/09:
Granted February 2006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Pregnancy and Childbirth: Anaesthesia
Intervention
Patients were randomised to receive
1. either phenylephrine at a rate of 16.6 µg min^1 (concentration 1µg ml^1) or ephedrine at a rate of 1.5 mg min^1 (concentration 90 µg ml^1)
2. varying doses of hyperbaric bupivacaine with fentanyl 25 µg using a double-blinded, up-down sequential allocation design
Intervention type
Drug
Phase
Not Specified
Drug names
ephedrine phenylephrine bupivacaine
Primary outcome measure
The ED50 of intrathecal heavy bupivacaine with 25mcg fentanyl required to achieve a block to touch to Xiphisternum in the ephedrine and phenylephrine groups.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing elective CS with a viable singleton foetus who require regional anaesthesia will be identified.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/02/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
London
W6 8RF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hammersmith Hospital NHS Trust (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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19411667
Publication citations
-
Results
Hennebry MC, Stocks GM, Belavadi P, Barnes J, Wray S, Columb MO, Lyons G, Effect of i.v. phenylephrine or ephedrine on the ED50 of intrathecal bupivacaine with fentanyl for caesarean section., Br J Anaesth, 2009, 102, 6, 806-811, doi: 10.1093/bja/aep095.