Cesarean Section Complications Clinical Trial
Official title:
Comparison of Continuous Infusion of Noradrenaline Versus Phenylephrine During Cesarean Section Under Spinal Anesthesia. A Randomized Controlled Trial
The aim of this double-blind randomized study will be to compare a fixed-rate prophylactic noradrenaline infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia
- Spinal anesthesia is the anesthetic technique of choice for elective cesarean section.
- Spinal anesthesia can be complicated by hypotension, with incidence exceeding 80%
occasionally. Hypotension can lead to nausea, emesis and a subjective feeling of
discomfort due to cerebral hypoperfusion. If left untreated, severe or sustained
hypotension can lead to decreased uteroplacental flow and fetal distress of premature or
compromised fetuses while severe complications to the parturient might ensue, such as
loss of consciousness, aspiration, apnea or cardiac arrest
- One of the standard techniques to avoid maternal hypotension is the administration of a
continuous phenylephrine infusion while studies have demonstrated its superiority as
compared to rescue bolus phenylephrine administration. Additionally, as compared to
ephedrine, phenylephrine is associated with less neonatal acidosis and better
maintenance of uteroplacental blood flow. However, phenylephrine can lead to
baroreceptor-mediated reflex bradycardia, with untoward consequences for maternal
cardiac output.
- Recently, noradrenaline has been shown to be effective in maintaining blood pressure in
obstetric patients. Noradrenaline is a strong-alpha agonist with weak beta-action, too.
Therefore, it might prove superior in maintaining cardiac output as compared to
phenylephrine. There have been a few studies examining the use of noradrenaline as a
continuous infusion in this context but the optimal dose and safety and efficacy profile
of noradrenaline continuous infusion in obstetrics is yet to be determined
- In all parturients, standard hemodynamic monitoring will be applied. Baseline systolic
arterial pressure will be considered the average of three consecutive measurements that
will not differ more than 10% among them. All parturients will have a peripheral
intravenous catheter placed in the upper extremity after baseline hemodynamic
measurements are recorded and will be infused 5 mL/kg of hydroxyethylstarch
(pre-loading) before the regional procedure.
- Study group allocation will taker place according to a computer-generated sequence of
random numbers. A standard spinal anesthetic consisting of ropivacaine 0.75% 1.8 mL plus
fentanyl 10 μg will be administered in the left lateraL position at the L3-4 or L4-5
vertebral interspace. The study infusion medication (either phenylephrine or
norepinephrine, depending on group allocation) will be started at the same time
cerebrospinal fluid is obtained, immediately before injection of spinal medications.
After the intrathecal injection, patients will placed in the supine position with a left
lateral tilt of the table to provide left uterine displacement and to prevent aortocaval
compression. The spinal sensory level will be tested bilaterally by pinprick to ensure a
T4 dermatomal level before surgical incision.
- Hemodynamic parameters (systolic arterial blood pressure, diastolic arterial blood
pressure, mean arterial blood pressure and heart rate) will be measured and recorded at
discrete timepoints throughout the operation (baseline, start of vasoactive agent
administration, parturient at supine position, sympathetic block at T4, knife-to-skin,
neonatal delivery, start of oxytocin administration, start of skin closure, end of
operation.
- During the operation, a rescue dose of phenylephrine 50 μg will be administered when
systolic arterial pressure drops below 80% of baseline in combination with heart rate>80
bpm. Ephedrine 5 mg will be administered when there is hypotension (systolic arterial
pressure <80% of baseline) in combination with heart rate less than 80 bpm. Hypertensive
episodes (systolic blood pressure >120% of baseline) will be treated with halving the
infusion while when systolic arterial pressure increases above 130% of baseline the
infusion will be discontinued and will be restarted when systolic blood pressure
decreases below the upper limit of the target range (120% of baseline value).
;
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