This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading. The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia
in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia
Aretaieion University Hospital
Athens, Greece
Alexandra General Hospital of Athens
Athens, Greece
incidence of hypotension
any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
Time frame: intraoperative
need for vasoconstrictor
any need for vasoconstrictor during the operation will be recorded
Time frame: intraoperative
type of vasoconstrictor administered
phenylephrine versus ephedrine
Time frame: intraoperative
total dose of vasoconstrictor administered
total dose in mg for ephedrine or μg for phenylephrine administered
Time frame: intraoperative
incidence of hypertension
any incidence of systolic blood pressure\>120% of baseline will be recorded
Time frame: intraoperative
incidence of bradycardia
any incidence of maternal bradycardia (heart rate\<60/min) will be recorded
Time frame: intraoperative
need for atropine
any need for atropine during the operation because of bradycardia will be recorded
Time frame: intraoperative
modification or cessation of the infusion
any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded
Time frame: intraoperative
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DOUBLE
Enrollment
100
incidence of nausea/vomiting
any occurence of nausea and/or vomiting during the operation will be recorded
Time frame: intraoperative
Neonatal Apgar score at 1 min
Neonatal Apgar score will be recorded at 1 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Time frame: 1 min post delivery
Neonatal Apgar score at 5 min
Neonatal Apgar score will be recorded at 5 min after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Time frame: 5 min post delivery
neonatal blood gases
fetal cord blood analysis will be performed immediately post-delivery
Time frame: 1 min post delivery
glucose in neonatal blood
glucose will be measured in the cord blood gas sample taken immediately post-delivery
Time frame: 1 min post delivery