Evaluation of equivalent effective dose of ephedrine and phenylephrine in prevention of hypotension after spinal anaesthesia for caesarean section

ISRCTN ISRCTN62049497
DOI https://doi.org/10.1186/ISRCTN62049497
Protocol serial number N0436130343
Sponsor Department of Health
Funder Leeds Teaching Hospitals NHS Trust
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
17/11/2010
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 S Saravanan
Scientific

Obstetric Anaesthesia Office
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone +44 (0)113 243 3144
Email r&d@leedsth.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesThe aim of this study is to determine whether ephedrine or phenylephrine or a combination provides the best prophylactic for prevention of hypotension after spinal anaesthesia
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Anaesthesia
InterventionRandomised controlled trial to determine whether ephedrine or phenylephrine or a combination provides the best prophylactic for prevention of hypotension after spinal anaesthesia.
Intervention typeOther
Primary outcome measure(s)

Efficacy in preventing cardiovascular instability
Uterine arterial blood gas analysis
Incidence of nausea and vomiting under anaesthetic

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/07/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Key inclusion criteriaWomen who have completed 36 weeks of normal pregnancy, fit and well normally and who are planned to have an elective caesarean section under spinal anaesthesia will be recruited
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/07/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Obstetric Anaesthesia Office
Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2006 Yes No