Hypotension Clinical Trial
Official title:
Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 120 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 are obtained, the study participants are randomly assigned
using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will consist of: An intravenous bolus of 0,2 mcg/Kg of norepinephrine to maintain
systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Group B will consist of: An intravenous bolus of 100mcg of phenylephrine to maintain systolic
blood pressure (SBP) within 80-120% of baseline before the spinal.
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 by taking the mean of three consecutive SBP measurements taken 5 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 endpoint is the number of provider interventions needed to maintain the SBP
within 100-120% of baseline for both groups. The secondary endpoint is nausea measured with
each provider intervention after induction of spinal anesthesia, and immediately following
delivery with 11 point verbal rating scale (0 = no nausea, 1 = nausea). Vomiting will be
recorded whenever present during the surgical procedure.
Bradycardia (HR less than 50 BPM) will be treated with Atropine 0.4mg IV or ephedrine 3 mg -
12 mg IV bolus.
Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric
bupivacaine (2 mL) plus sufentanil (5 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 Phenylephrine or norepinephrine bolus. 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, the
number and type of interventions for control of blood pressure, heart rate, incidence of
nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at
delivery.
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