A comparison of speed of action of phenylephrine and ephedrine
| ISRCTN | ISRCTN42749317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42749317 |
| Secondary identifying numbers | N0521113691 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Dr D Thomas
Scientific
Scientific
University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A comparison of speed of action of phenylephrine and ephedrine |
| Study objectives | Does phenylephrine allow more rapid control of maternal arterial pressure during obstetric spinal anaesthesia than ephedrine? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Phenylephrine and ephedrine |
| Primary outcome measure | Ttime to peak vasopressor effect on systolic arterial pressure |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/03/2002 |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | No data is available to guide sample size estimations. |
| Key inclusion criteria | Healthy women having elective caesarean section at term will be recruited. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 27/03/2002 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital of North Durham
Durham
DH1 5TW
United Kingdom
DH1 5TW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
County Durham and Darlington Acute Hospitals NHS Trust (North) (UK)
No information available
Results and Publications
| 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 |
Editorial Notes
25/03/2020: No publications found, all search options exhausted, study status unverified.
