The effect of ephedrine and phenylephrine on the ED50 of intrathecal bupivacaine required to provide anaesthesia for Caesarean section

ISRCTN ISRCTN32635781
DOI https://doi.org/10.1186/ISRCTN32635781
Secondary identifying numbers N0016176701
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
28/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gary Stocks
Scientific

Department of Anaesthesia
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesTo 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(s)Added as of 28/07/09:
Granted February 2006
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Anaesthesia
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)ephedrine phenylephrine bupivacaine
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/02/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants70
Key inclusion criteriaPatients undergoing elective CS with a viable singleton foetus who require regional anaesthesia will be identified.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/02/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
London
W6 8RF
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Hammersmith Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2009 Yes No