We plan to study women having elective, low-risk, Caesarean sections under spinal anaesthesia. Hypotension is very frequent with spinal anaesthesia in this patient population and it usually requires treatment with intravenous vasopressors. This study will compare the effect, if any, on the spread of spinal anaesthesia, when either of the two most commonly used intravenous vasopressors are given to treat hypotension. We are not studying a disease.
Conditions
Interventions
Trade Name: Phenylephrine injection BP
Product Name: Phenylephrine hydrochloride Ph Eur 1% w/v
Pharmaceutical Form: Intravenous infusion
Trade Name: Ephedrine Hydrochloride Injection
Product Name: Ep
Sponsors
South Tees Acute Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will study healthy women with low-risk pregnancies having spinal anaesthesia for elective Caesarean sections. Inclusion Criteria: - Patients of American Society of Anesthesiologists Category 1-2 scheduled for elective Caesarean section under spinal anaesthesia. - Singleton fetus, at least 36 weeks gestation, with no known abnormality. - Under the care of a specialist Obstetrician at the James Cook University Hospital who consents to his/her patients being included in the trial. - Patients giving informed consent to participate in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Anaesthetist is unable to perform spinal anaesthesia. - Pregnancy induced hypertension. - Diabetes. - Hypersensitivity to any of the study drugs. - Anticoagulant therapy. - Age < 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This main objective of the study is to test the hypothesis that: ‘Giving intravenous phenylephrine to maintain arterial pressure during spinal anaesthesia for Caesarean section reduces rostral spread of spinal hyperbaric bupivacaine, compared with giving intravenous ephedrine.’ This will be done by comparing block height to cold at 15 minutes post-spinal, when either phenylephrine, or ephedrine has been given as the first line vasopressor.;Secondary Objective: The secondary objective will be to assess if there is any difference in the quality of spinal anaesthesia when either phenylephrine or ephedrine is given as the first line vasopressor. This will be done by comparing the incidence of inadequate block, and by comparing the incidence of unnecessarily high block, in the two groups. ;Primary end point(s): Patients will be given a standard spinal anaesthetic into the lower back (lumbar spine). Spinal anaesthetic spreads towards the head causing ascending numbess. The primary end point is a difference in the level of numbness (block height) to cold sensation of at least one spinal segment (dermatome) at 15-minutes post-spinal. The secondary end points are the incidence of unnecessarily high block and the incidence of block which is not high enough. We will study a total of 126 patients and then the study will stop. | — |
Countries
United Kingdom
Outcome results
None listed