Comparison of Prophylactic Infusion of Phenylephrine Versus Norepinephrine for the Prevention of Post Spinal Hypotension in Parturients Undergoing Elective Caesarean Section-a Randomized, Double-Blinded, Non-Inferiority Trial.

Abstract

Objective: Postspinal hypotension occurs in nearly 50% of women undergoing cesarean section (CS). Although phenylephrine (PE) is currently the vasopressor of choice, severe maternal bradycardia may adversely affect the fetal status due to the reduction in the maternal cardiac output. Norepinephrine (NE) is not associated with bradycardia and is now being evaluated for the treatment of post-spinal hypotension in obstetric patients. The hypothesis of this study was that the prophylactic NE infusion was non-inferior to PE infusion when used for the prevention of postspinal hypotension.

Methods: This was a randomized, double-blinded controlled study conducted in 130 parturients scheduled for CS. The participants received either prophylactic NE (5 μg min^-1) or PE (25 μg min^-1) infusion beginning at the time of spinal injection. The primary outcome was the incidence of hypotension in both groups. Maternal bradycardia, reactive hypertension, nausea and vomiting, requirement of rescue boluses of vasopressor and/or atropine, and neonatal acid base status were also recorded.

Results: The incidence of hypotension was 33.80% (22 of 65) in Group PE and 26.10% (17 of 65) in Group NE (P=0.85). The absolute risk difference [90% confidence interval (CI)] in the incidence of hypotension between the groups was -7.7% (-20.9, 5.4). The upper limit of the CI was less than the non-inferiority margin of 20%, indicating that the NE infusion was non-inferior to PE.

Conclusion: Prophylactic infusion of NE is not inferior to prophylactic PE infusion in the prevention of postspinal hypotension in patients undergoing CS.