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Clinical Trials/NCT02542748
NCT02542748
Completed
Not Applicable

Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study

Air Force Military Medical University, China1 site in 1 country66 target enrollmentOctober 5, 2015

Overview

Phase
Not Applicable
Intervention
Norepinephrine
Conditions
Hypotension
Sponsor
Air Force Military Medical University, China
Enrollment
66
Locations
1
Primary Endpoint
incidence of hypotension
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2015
End Date
June 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Zhihong LU

Dr

Air Force Military Medical University, China

Eligibility Criteria

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

Arms & Interventions

norepinephrine

norepinephrine is injected after spinal anesthesia

Intervention: Norepinephrine

ephedrine

ephedrine is injected after spinal anesthesia

Intervention: Ephedrine

Outcomes

Primary Outcomes

incidence of hypotension

Time Frame: from immediately after spinal anesthesia to 30min after spinal anesthesia

Secondary Outcomes

  • pH value of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
  • lowest neonatal cerebral oxygen saturation(from clamp of the umbilical cord to 10 min later, 10min in total)
  • lactate level of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
  • number of rescue vasoactive agent(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • incidence of bradycardia(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • incidence of dizzy(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • fetal arterial partial pressure of oxygen(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
  • arterial base excess of fetal arterial blood(just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery)
  • incidence of nausea and vomiting(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • incidence of chest congestion(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • incidence of dyspnea(from immediately after spinal anesthesia to 30min after spinal anesthesia)
  • Apgar scores of the neonates(from clamp of umbilical cord to 5min after clamping)

Study Sites (1)

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