The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.
The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy. Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones. According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation. Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava. The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
200 µg of a 100 µg/ml solution, intrathecally
25 ml/min intravenously
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy
Neonatal arterial base excess
Time frame: <5 min from birth
Neonatal arterial and venous pH, venous base excess
Time frame: <5 min from birth
Apgar score
Time frame: 1 and 5 minutes from birth
Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)
Time frame: Baseline and up to 12 h postoperatively
Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).
Time frame: q5min from anesthesia to end of surgery
Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)
Time frame: q5min from anesthesia to end of surgery
Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.
Time frame: q5min from anesthesia to end of surgery
Administered atropine
Time frame: from anesthesia to end of surgery
Amount of ephedrine administered (mg)
Time frame: from anesthesia to end of surgery
Time between induction of anesthesia and skin incision
Time between skin incision and delivery
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37.5 mg/h intravenously
6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.
0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.