Anesthesia Clinical Trial
Official title:
Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
This study will be a prospective, randomized, active treatment controlled trial.
After written and informed consent, the study participants will be randomly assigned using a
computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will receive an intravenous bolus of 1mcg/Kg of norepinephrine bitartrate to maintain
systolic blood pressure (SBP) within 80-120% of baseline before the spinal anesthesia.
Group B will receive an intravenous bolus of 0.5mcg/kg of norepinephrine bitartrate to
maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal
anesthesia.
Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate
will be measured in supine position, with left uterine displacement. Baseline blood pressure
will be calculated as the mean of three consecutive SBP measurements taken 3 minutes apart.
500 mL of Lactated Ringers solution will be administered immediately after induction of
spinal anesthesia at the outflow rate of 100ml per hour.
The primary endpoints are:
the timing of the first maternal hypotension before delivery (defined as a decrease of SBP
>20% of baseline and/or PAS<100mmHg) the delta PAS and delta PAM before delivery ( difference
between basline and the lowest systolic and mean blood pressure respectively)
The secondary endpoints are:
Incidence of hypotension,norepinephrine consumption (mean dose of Norepinephrine to maintain
blood pressure between 80 and 100 % of baseline values after the primary preventive bolus),
nausea and vomiting will be recorded whenever present during the surgical procedure as well
as reactive hypertension (defined as a rise of SBP >20% of baseline or SBP>140mmHg) and
arrhythmia. Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.5mg IV. Fetal
cord blood analysis will be done immediately after delivery in order to determine the pH
value ( ie : logarithm of the blood concentration of hydrogen ions H+)in each group
Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric
bupivacaine (2 mL) with either sufentanil (5 mcg) or fentanyl (50 mcg) at L3-4 or L4-5. Prior
to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4
dermatomal level. The patients will be positioned supine with a wedge placed under the right
hip to avoid aortocaval compression. Both the patient and the researcher's assistant (who
will collect data) will be blinded as to the administered Norepinephrine bolus A or B.
When PAS<80% of baseline or < 100 mmHg a bolus of Norepinephrine will be administrated(half
dose A or B).
The study will end when cesarean section is completed and the patient transferred to the
post-operative care unit.
Measured variables will include systolic, diastolic and mean non-invasive blood pressure,
heart rate, number of rescue boluses , incidence of nausea and vomiting (NV), incidence of
arrhythmia, Apgar score and fetal cord blood analysis (pH) at delivery.
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