A randomized controlled trial of variable rate phenylephrine infusion with rescue phenylephrine boluses versus rescue boluses alone on physician interventions during spinal anesthesia for elective cesarean delivery.

BACKGROUND: Phenylephrine infusion is used to reduce hypotension during spinal anesthesia for cesarean delivery. A prophylactic fixed rate infusion regimen may not improve hemodynamic control; a variable rate regimen adjusted in response to changes in arterial blood pressure and heart rate may allow more accurate maintenance of baseline blood pressure. We hypothesized that a combination of crystalloid solution coload with a variable rate phenylephrine infusion and phenylephrine rescue boluses may be associated with fewer physician interventions needed to maintain maternal systolic blood pressure within 20% of baseline and greater hemodynamic stability than crystalloid solution coload with phenylephrine rescue boluses alone.
METHODS: In this prospective, double-blind study, 80 patients received a coload with 15 mL/kg lactated Ringer's solution immediately after the initiation of spinal anesthesia. Patients were randomized to receive a prophylactic variable rate phenylephrine infusion starting at 0.75 μg/kg/min (group P) or infusion of normal saline (group S). Maternal systolic blood pressure was maintained within 20% of baseline with rescue phenylephrine boluses using a preset algorithm. During the predelivery period, the number of physician interventions (primary outcome), hemodynamic performance, nausea/vomiting, and umbilical cord blood gas values were compared between the groups.
RESULTS: One patient from group S was excluded due to protocol violation. Therefore, group P included 40 patients and group S 39 patients. The median (range) number of physician interventions needed to maintain maternal hemodynamics within the target range (0 [0-6] vs 3 [0-9], difference in median: 3, 95% confidence interval of difference: 2-4) and incidence of hypotension (8/40 [20%] vs 35/39 [90%]) were lower in group P compared with group S (P < 0.001). Group P had a higher incidence of hypertension compared with group S (6/40 [15%] vs 0/39 [0%], P = 0.026). The median performance error was closer to baseline (P < 0.001) with a smaller median absolute performance error (P = 0.001) in group P versus group S. In group P, 4/40 (10%) patients had nausea/vomiting compared with 17/39 (44%) in group S (P = 0.001). The number needed to treat was 1.4 women to prevent 1 case of hypotension, and 3 women to prevent 1 case of nausea/vomiting; the rate of hypertension was 1 case per 6.7 women treated. Neonatal outcomes were not different between the 2 groups.
CONCLUSION: Prophylactic variable rate phenylephrine infusion and rescue phenylephrine bolus dosing is more effective than relying on rescue phenylephrine bolus dosing with respect to limiting clinician workload and maternal symptoms during spinal anesthesia for cesarean delivery.

RCT Entities:   Population Interventions Outcomes