Prophylactic ephedrine and hypotension during spinal anaesthesia for elective Caesarean section
| ISRCTN | ISRCTN26979860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26979860 |
| Protocol serial number | N0187122160 |
| Sponsor | Department of Health (UK) |
| Funder | Portsmouth NHS Research and Development Consortium (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/02/2014
- 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 Ian Taylor
Scientific
Scientific
Anaesthetics Department
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)23 9228 6000 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The majority of elective Caesarean section operations are performed using a spinal anaesthetic. One of the common problems with this technique is a fall in the patient's blood pressure - occurring in approximately 70% of cases. At present we closely monitor blood pressure and treat any fall with fluids and/or intravenous drugs (usually ephedrine) as it occurs. The aim of this study is to assess whether or not the frequency of a fall in blood pressure can actually be avoided by the use of ephedrine before a drop occurs. Secondly, if prophylactic ephedrine is of benefit we hope to find out which is the best way to administer the drug: either by a bolus or by a continuous infusion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Anaesthesia |
| Intervention | 1. Ephedrine infusion 2. Ephedrine bolus 3. Saline |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 105 |
| Key inclusion criteria | A total of 105 patients (35 per group) age >16 years. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 18/11/2002 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthetics Department
Portsmouth
PO6 3LY
United Kingdom
PO6 3LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
