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Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

Not Applicable
Completed
Conditions
Hypotension
Obstetrical Complication of Anesthesia
Complications; Cesarean Section
Interventions
Registration Number
NCT02542748
Lead Sponsor
Air Force Military Medical University, China
Brief Summary

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.

Detailed Description

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. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
66
Inclusion Criteria
  • Patients scheduled for elective cesarean section
Exclusion Criteria
  • Patients with severe pre-eclampsia
  • Patients with contraindications for spinal anesthesia
  • Patients with multiple pregnancy
  • Patients with gestation <38w

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
norepinephrineNorepinephrinenorepinephrine is injected after spinal anesthesia
ephedrineEphedrineephedrine is injected after spinal anesthesia
Primary Outcome Measures
NameTimeMethod
incidence of hypotensionfrom immediately after spinal anesthesia to 30min after spinal anesthesia
Secondary Outcome Measures
NameTimeMethod
pH value of fetal arterial bloodjust after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
lowest neonatal cerebral oxygen saturationfrom clamp of the umbilical cord to 10 min later, 10min in total
lactate level of fetal arterial bloodjust after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
number of rescue vasoactive agentfrom immediately after spinal anesthesia to 30min after spinal anesthesia
incidence of bradycardiafrom immediately after spinal anesthesia to 30min after spinal anesthesia
incidence of dizzyfrom immediately after spinal anesthesia to 30min after spinal anesthesia
fetal arterial partial pressure of oxygenjust after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
arterial base excess of fetal arterial bloodjust after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
incidence of nausea and vomitingfrom immediately after spinal anesthesia to 30min after spinal anesthesia
incidence of chest congestionfrom immediately after spinal anesthesia to 30min after spinal anesthesia
incidence of dyspneafrom immediately after spinal anesthesia to 30min after spinal anesthesia
Apgar scores of the neonatesfrom clamp of umbilical cord to 5min after clamping

The Apgar score is a method to quickly summarize the health of newborn children.It is determined by evaluating the newborn baby on five simple criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts

Trial Locations

Locations (1)

Xijing Hospital,Fourth Military Medical University

🇨🇳

Xi'an, Shaanxi, China

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