Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Thomas

ORCID ID

Contact details

University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0521113691

Study information

Scientific title

A comparison of speed of action of phenylephrine and ephedrine

Acronym

Study hypothesis

Does phenylephrine allow more rapid control of maternal arterial pressure during obstetric spinal anaesthesia than ephedrine?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and Childbirth: Anaesthesia

Intervention

Phenylephrine vs ephedrine

A standardised anaesthetic technique will be used. Maternal arterial pressure will be measured by an automated oscillometric device (Cardiocap II, Datex Instrumentarium) and by a continuous, non-invasive photoplethysmographic device using a finger probe (Finapres 2300, Ohmeda). Boluses of phenylephrine 100 ug or ephedrine 6 mg will be given whenever systolic arterial pressure falls by 15% from the prespinal value. An analog arterial pressure waveform will be recorded using a PowerLab 8sp recording and analysis device (AD Instruments Inc). This time from administration of vasopressor to time of peak effect on arterial pressure will then be analysed.

Intervention type

Drug

Phase

Not Specified

Drug names

Phenylephrine and ephedrine

Primary outcome measures

Ttime to peak vasopressor effect on systolic arterial pressure

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/03/2002

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy women having elective caesarean section at term will be recruited.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

No data is available to guide sample size estimations.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

27/03/2002

Recruitment end date

30/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Durham
Durham
DH1 5TW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

County Durham and Darlington Acute Hospitals NHS Trust (North) (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

Publication citations

Additional files

Editorial Notes