The effect of ephedrine and phenylephrine on the ED50 of intrathecal bupivacaine required to provide anaesthesia for Caesarean section
ISRCTN | ISRCTN32635781 |
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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
Scientific
Department of Anaesthesia
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Other |
Scientific title | |
Study objectives | 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(s) | Added as of 28/07/09: Granted February 2006 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2006 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 70 |
Key inclusion criteria | Patients undergoing elective CS with a viable singleton foetus who require regional anaesthesia will be identified. |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 01/02/2006 |
Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/06/2009 | Yes | No |