Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGDifference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery
Time frame: From the start of spinal anesthesia until delivery
Number of patients receiving rescue vasopressor
Systolic blood pressure \<90% of baseline value
Time frame: From the start of spinal anesthesia until delivery
Incidence of hypotension
Systolic blood pressure \<80% of baseline value
Time frame: From the start of spinal anesthesia until delivery
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Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Incidence of severe hypotension
Systolic blood pressure \<70% of baseline value
Time frame: From the start of spinal anesthesia until delivery
Incidence of bradycardia
Heart rate \<50 beats/min
Time frame: From the start of spinal anesthesia until delivery
Incidence of nausea and/or vomiting
Time frame: From the start of spinal anesthesia until delivery
Total vasopressor dose
Time frame: From the start of spinal anesthesia until delivery
Neonatal Apgar score at 1 and 5 minutes after delivery
Scale from 0 to 10. Higher scores mean better outcomes.
Time frame: 1 and 5 minutes after delivery