RESUMO
BACKGROUND: The hemodynamic effects of relatively low-dose epinephrine and phenylephrine infusions during cesarean delivery under spinal anesthesia were compared. METHODS: This randomized controlled trial included full-term pregnant women who underwent elective cesarean delivery. After spinal anesthesia, participants received either epinephrine (0.03 mcg/kg/min) or phenylephrine (0.4 mcg/kg/min) infusion that continued until 5 min after delivery. The primary outcome was a composite outcome of the occurrence of any of hypotension, hypertension, bradycardia, and/or tachycardia. Neonatal outcomes, including umbilical artery blood gas and Apgar scores, were assessed. RESULTS: In total, 98 patients in each group were analyzed, and the number of patients with the composite outcome was comparable between the epinephrine and phenylephrine groups (30/98 [31%] vs. 31/98 [32%], respectively; P = 0.877). However, the incidence of hypotension was likely lower in the epinephrine group than in the phenylephrine group (P = 0.066), and the number of hypotensive episodes per patient was lower in the epinephrine group than in the phenylephrine group. On the other hand, the incidence of tachycardia was higher in the epinephrine group than that in the phenylephrine group. The incidence of hypertension was comparable between the two groups and none of the participants developed bradycardia. Neonatal outcomes were comparable between the two groups. CONCLUSIONS: Epinephrine and phenylephrine infusion produced comparable maternal hemodynamics and neonatal outcomes. Epinephrine was associated with a higher incidence of maternal tachycardia and likely lower incidence of maternal hypotension than phenylephrine. IRB number: MD-245-2022. CLINICAL TRIAL REGISTRATION: This study was registered on May 31, 2023 at clinicaltrials.gov registry, NCT05881915, URL: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05881915term=NCT05881915&draw=2&rank=1.
Assuntos
Anestesia Obstétrica , Raquianestesia , Cesárea , Epinefrina , Hipotensão , Fenilefrina , Vasoconstritores , Humanos , Feminino , Cesárea/métodos , Raquianestesia/métodos , Raquianestesia/efeitos adversos , Gravidez , Fenilefrina/administração & dosagem , Adulto , Hipotensão/prevenção & controle , Hipotensão/epidemiologia , Epinefrina/administração & dosagem , Vasoconstritores/administração & dosagem , Vasoconstritores/uso terapêutico , Anestesia Obstétrica/métodos , Anestesia Obstétrica/efeitos adversos , Infusões Intravenosas , Recém-NascidoRESUMO
BACKGROUND: This study aimed to compare three epinephrine doses for the prevention of spinal hypotension during Caesarean delivery. METHODS: This randomized controlled trial included full-term pregnant women undergoing elective Caesarean delivery under spinal anesthesia. The participants received prophylactic epinephrine infusions at rates of 0.01, 0.02, or 0.03 mcg/kg/min. Spinal hypotension (systolic blood pressure <80% of baseline) was managed with a 9-mg ephedrine bolus. The primary outcome was the incidence of spinal hypotension. Secondary outcomes included total ephedrine requirement, the incidence of severe spinal hypotension, excessive tachycardia and hypertension, and neonatal outcomes. RESULTS: The final analysis included 271 patients. The incidence of hypotension was lowest in the 0.03 mcg group (11/90 [12%]), followed by the 0.02 mcg (32/91 [35%]) and the 0.01 mcg (55/90 [61%]) groups (p < 0.001). The median ephedrine requirements (quartiles) were also the lowest in the 0.03 mcg group (0 [0-0] mg), followed by the 0.02 mcg (0 [0-9] mg) and the 0.01 mcg (9 [0-18] mg) groups. The incidence of severe hypotension was lower in the 0.03 mcg and 0.02 mcg groups than in the 0.01 mcg group (3/90 [3%], 5/91 [6%], and 15/90 [17%], respectively). The incidences of excessive tachycardia, hypertension, and neonatal outcomes were comparable among the groups. CONCLUSION: The use of epinephrine to prevent spinal hypotension during Caesarean delivery is feasible and effective. An initial dose of 0.03 mcg/kg/min produced the lowest incidence of hypotension compared to 0.02 mcg/kg/min and 0.01 mcg/kg/min doses. The three doses were comparable in terms of the incidence of tachycardia, hypertension, and neonatal outcomes. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT05279703.
Assuntos
Anestesia Obstétrica , Raquianestesia , Hipertensão , Hipotensão , Recém-Nascido , Feminino , Humanos , Gravidez , Efedrina/uso terapêutico , Vasoconstritores/uso terapêutico , Hipotensão/epidemiologia , Hipotensão/etiologia , Hipotensão/prevenção & controle , Epinefrina/uso terapêutico , Hipertensão/tratamento farmacológico , Raquianestesia/efeitos adversos , Anestesia Obstétrica/efeitos adversos , Cesárea/efeitos adversos , Método Duplo-CegoRESUMO
BACKGROUND: Data on the best norepinephrine bolus dose for management of hypotension are limited. The aim of this study was to compare the efficacy and safety of two norepinephrine bolus doses in the rescue management of maternal hypotension during cesarean delivery. METHODS: This randomized, controlled trial included mothers scheduled for cesarean delivery with spinal anesthesia with a prophylactic norepinephrine infusion. Following spinal anaesthesia administration, a participant was considered hypotensive if systolic blood pressure was ≤80% compared to the baseline reading. Participants were allocated to receive either 6 mcg or 10 mcg norepinephrine bolus for the management of hypotensive episodes. The hemodynamic response after administration of norepinephrine bolus was recorded. The episode was considered successfully managed if systolic blood pressure returned to within 80% from the baseline reading within 2 min after norepinephrine bolus administration, and did not drop again within 6 min after the norepinephrine bolus. The primary outcome was the incidence of successful management of the first hypotensive episode. Other outcomes included systolic blood pressure, heart rate, incidence of maternal bradycardia, and reactive hypertension. RESULTS: One hundred and ten mothers developed hypotensive episodes and received norepinephrine boluses for management. The number of successfully managed first hypotensive episodes was 50/57 (88%) in the 6 mcg-treated episodes and 45/53 (85%) in the 10 mcg-treated episodes (p = 0.78). Systolic blood pressure was comparable after administration of either bolus dose. Heart rate was lower after administration of 10 mcg bolus compared to 6 mcg bolus, without significant bradycardia requiring atropine administration. The incidence of reactive hypertension was comparable between both groups. CONCLUSION: In mothers undergoing elective cesarean delivery under prophylactic norepinephrine infusion at 0.05 mcg/kg/min, there was no advantage to the use of 10 mcg norepinephrine bolus over 6 mcg norepinephrine bolus for the rescue management of first hypotensive episode. Neither of the 2 bolus doses reached a 100% success rate. The incidences of bradycardia and reactive hypertension were comparable between both norepinephrine doses. TRIAL REGISTRATION: At clinicaltrial.gov registry system on January 4, 2019 Clinical trial identifier: NCT03792906.