Cesarean Section, Hypotension
Conditions
Keywords
post spinal anesthesia
Brief summary
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.
Detailed description
Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.
Interventions
DRUGNorepinephrine
prophylaxis for hypotension
DRUGPhenylephrine
standerd prophylaxis for hypotension
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.
Exclusion criteria
* Patient refusal either to study enrollment or to spinal anesthesia. * Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection. * Allergy to any of study drugs. * Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding * BMI \> 40 kg/m² * Baseline systolic blood pressure \< 100 mmHg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotensive episodes. | 15-20 minutes | Hypotension is defined as \<80% of baseline or systolic blood pressure (SBP) \<100 mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of reactive hypertension | 20 minutes | defined as \>120% of baseline. |
| nausea and vomiting | 20 minutes | Incidence of nausea and vomiting attacks. |
| Total dose of vasopressor | 20 minutes | Total dose of vasopressor used. |
| Incidence of maternal bradycardia. | 15-20 minutes | Bradycardia is defined as heart rate (HR) \< 50 beats/min |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fetal outcome | at 1, 5 and 8 minutes | APGAR score |
| mixed blood gas | 1 minute after delivery | Umbilical artery and vein blood gas |
| Admission to neonatal ICU (NICU) | first 24 hours after delivery | the need for NICU admission |
Countries
Egypt
Outcome results
None listed