The purpose of this study is to determine the 50% and 90% effective doses (ED50 and ED90) of prophylactic phenylephrine infusion for preventing spinal anesthesia-induced hypotension during elective cesarean delivery, in the supine position and in the left-lateral-tilt 15° position, respectively. Two hundred parturients with singleton term pregnancies will be randomized 1:1 to the supine group or the left-tilt 15° group, and within each position 1:1:1:1 to one of four fixed phenylephrine infusion rates (0.2, 0.4, 0.6, or 0.8 μg/kg/min; 25 per group), with the rate allocation masked by concentration blinding (identical pump rate, different solution concentrations). Spinal anesthesia consists of hyperbaric bupivacaine 12 mg plus morphine 0.15 mg. The primary outcome is the incidence of hypotension (systolic blood pressure \< 80% of baseline or \< 90 mmHg) from completion of the intrathecal injection to delivery. ED50 and ED90 will be estimated by probit regression within each position.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Prophylactic fixed-rate IV infusion (pump rate 0.6 mL/kg/h, concentration-blinded), from completion of spinal anesthesia until delivery
Department of Anesthesiology,Xuzhou HeJia Hospital, Xuzhou, Jiangsu, China
Xuzhou, Jiangsu, China
hypotension incidence of hypotension from completion of intrathecal injection to delivery of the infant
Hypotension defined as systolic blood pressure \< 80% of baseline (measured in the assigned study position) or \< 90 mmHg
Time frame: From completion of spinal anesthesia to fetal delivery
Umbilical artery and umbilical vein blood gas values
Umbilical artery and umbilical vein blood gas values (pH, PCO2, PO2, base excess, lactate)
Time frame: At delivery
Apgar scores at 1 and 5 minutes after delivery
Time frame: From fetal delivery to 5 minutes after delivery
Time to first rescue vasopressor
Time frame: From completion of intrathecal injection to delivery
Serial systolic blood pressure values within 12 minutes after intrathecal injection
Time frame: From completion of spinal anesthesia to 12 minutes after completion of spinal anesthesia
Incidence of hypertension before delivery
Incidence of hypertension (systolic blood pressure ≥ 120% of baseline) before delivery
Time frame: From completion of intrathecal injection to delivery
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