three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia). Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
284
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
Cairo University
Cairo, Egypt
postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Time frame: 30 minutes after spinal anesthesia
severe postspinal hypotension
The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
Time frame: 30 minutes after spinal anesthesia
Post-delivery hypotension
number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)
Time frame: 10 minutes after delivery
systolic blood pressure
systolic blood pressure measured in mmHg
Time frame: 60 minutes after spinal block
diastolic blood pressure
diastolic blood pressure measured in mmHg
Time frame: 60 minutes after spinal block
heart rate
heart rate measured in beats per minute
Time frame: 60 minutes after spinal block
intraoperative hypertension
number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group
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The patient will receive spinal anesthesia using Bupivacaine (10 mg).
Time frame: 60 minutes after spinal block
incidence of nausea and vomiting
number of patients who develop nausea and vomiting divided by the total number of patients in the group
Time frame: 60 minutes after spinal block
ephedrine consumption
total amount of ephedrine consumed during the operation (measured in milligrams)
Time frame: 60 minutes after spinal block
Atropine consumption
total amount of atropine consumed during the operation (measured in milligrams)
Time frame: 60 minutes after spinal block
APGAR score
APGAR score for detection of the well being of the fetus
Time frame: 1 minute after delivery
APGAR score
APGAR score for detection of the well being of the fetus
Time frame: 10 minutes after delivery