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Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial.

Moslemi F, Rasooli S - Iran J Med Sci (2015)

Bottom Line: There was an insignificant difference in demographic data between the groups.Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus.IRCT2012120911700N1.

View Article: PubMed Central - PubMed

Affiliation: Women's Reproductive Health Research Center, Department of Anesthesiology, Alzahra Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.

ABSTRACT

Background: Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section.

Methods: Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation) were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded.

Results: There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (P<0.05). In addition, the fifth-minute Apgar score of neonates was higher in phenylephrine and ephedrine groups than the control group (P<0.05). Neonates of phenylephrine group had less acidosis than the other groups.

Conclusion: Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus.

Trial registration number: IRCT2012120911700N1.

No MeSH data available.


Related in: MedlinePlus

Flow chart of patients enrolled to the study.
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Figure 1: Flow chart of patients enrolled to the study.

Mentions: The inclusion criteria were; healthy pregnant women with gestational age of 36 weeks or higher and non-emergency cesarean section. The exclusion criteria were; <36 weeks of gestation, emergency cesarean section, high risk pregnancies (multiple gestations, intrauterine growth retardation, preeclampsia maternal cardiovascular or pulmonary diseases), any contraindication of spinal anesthesia (patient refusal, coagulopathy, hemorrhage or hypovolemic shock) and unexpected events during surgery such a hemorrhage or sensory block level higher or lower than T4-T5 after spinal anesthesia. There were three groups of 30 patients. Group Ph (phenylephrine), group E (Ephedrine), and group P (placebo) as shown in figure 1. Upon arrival to the operating room, all patients were monitored for basal vital signs (HR, systolic and diastolic BPs, and Sao2). Two IV lines were placed for each patient, one for fluid infusion, and the other for infusion of prophylactic study drugs or placebo. Before performing spinal anesthesia, all patients received 500cc crystalloid from fluid IV line. Thereafter, infusion of study drugs was started as follows: group Ph received 450 μg phenylephrine in 250cc from the other IV line with infusion pump at a highest infusion rate for the pump (250cc in 30 minutes). Group E administered 45 mg ephedrine in 250cc normal saline from the same pump with the same infusion rate. Group P received an infusion of only 250cc normal saline in the same manner as mentioned above. All infusion solutions were prepared previously and were labeled with numerical codes. The nurses who infused the solutions and monitored vital signs and other clinical signs throughout the surgery were blinded to the solutions. After completion of fluid infusions all patients received spinal anesthesia by an anesthesiologist, in sitting position from L4-L5 or L3-L4 inter vertebral spaces with 2.5cc of Bupivacaine 0.5% (12.5 mg) and 2.5 μg sufentanil (total drug volume was 3.5cc). Immediately after spinal anesthesia, all patients were positioned in the supine position with left uterine displacement. BP was controlled every two minutes until delivery and then every five minutes throughout anesthesia. HR and Sao2 were monitored throughout anesthesia. Sensory block was monitored to obtain a T4-T5 level of anesthesia. Too high or too low sensory levels were excluded from the study. After delivery and clamping of umbilical cord, 1cc blood was drawn from the umbilical artery for neonatal blood gas analysis.


Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial.

Moslemi F, Rasooli S - Iran J Med Sci (2015)

Flow chart of patients enrolled to the study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4300475&req=5

Figure 1: Flow chart of patients enrolled to the study.
Mentions: The inclusion criteria were; healthy pregnant women with gestational age of 36 weeks or higher and non-emergency cesarean section. The exclusion criteria were; <36 weeks of gestation, emergency cesarean section, high risk pregnancies (multiple gestations, intrauterine growth retardation, preeclampsia maternal cardiovascular or pulmonary diseases), any contraindication of spinal anesthesia (patient refusal, coagulopathy, hemorrhage or hypovolemic shock) and unexpected events during surgery such a hemorrhage or sensory block level higher or lower than T4-T5 after spinal anesthesia. There were three groups of 30 patients. Group Ph (phenylephrine), group E (Ephedrine), and group P (placebo) as shown in figure 1. Upon arrival to the operating room, all patients were monitored for basal vital signs (HR, systolic and diastolic BPs, and Sao2). Two IV lines were placed for each patient, one for fluid infusion, and the other for infusion of prophylactic study drugs or placebo. Before performing spinal anesthesia, all patients received 500cc crystalloid from fluid IV line. Thereafter, infusion of study drugs was started as follows: group Ph received 450 μg phenylephrine in 250cc from the other IV line with infusion pump at a highest infusion rate for the pump (250cc in 30 minutes). Group E administered 45 mg ephedrine in 250cc normal saline from the same pump with the same infusion rate. Group P received an infusion of only 250cc normal saline in the same manner as mentioned above. All infusion solutions were prepared previously and were labeled with numerical codes. The nurses who infused the solutions and monitored vital signs and other clinical signs throughout the surgery were blinded to the solutions. After completion of fluid infusions all patients received spinal anesthesia by an anesthesiologist, in sitting position from L4-L5 or L3-L4 inter vertebral spaces with 2.5cc of Bupivacaine 0.5% (12.5 mg) and 2.5 μg sufentanil (total drug volume was 3.5cc). Immediately after spinal anesthesia, all patients were positioned in the supine position with left uterine displacement. BP was controlled every two minutes until delivery and then every five minutes throughout anesthesia. HR and Sao2 were monitored throughout anesthesia. Sensory block was monitored to obtain a T4-T5 level of anesthesia. Too high or too low sensory levels were excluded from the study. After delivery and clamping of umbilical cord, 1cc blood was drawn from the umbilical artery for neonatal blood gas analysis.

Bottom Line: There was an insignificant difference in demographic data between the groups.Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus.IRCT2012120911700N1.

View Article: PubMed Central - PubMed

Affiliation: Women's Reproductive Health Research Center, Department of Anesthesiology, Alzahra Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.

ABSTRACT

Background: Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section.

Methods: Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation) were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded.

Results: There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (P<0.05). In addition, the fifth-minute Apgar score of neonates was higher in phenylephrine and ephedrine groups than the control group (P<0.05). Neonates of phenylephrine group had less acidosis than the other groups.

Conclusion: Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus.

Trial registration number: IRCT2012120911700N1.

No MeSH data available.


Related in: MedlinePlus