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NCT Number: NCT02542748

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Complications; Cesarean Section Obstetrical Complication of Anesthesia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

norepinephrine injection

Other names: vasoactive agents

Ephedrine

Drug

Ephedrine injection

Other names: vasoactive agents

Primary outcomes

  1. incidence of hypotension

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

Secondary outcomes

  1. pH value of fetal arterial blood

    Time frame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  2. incidence of nausea and vomiting

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

  3. incidence of dizzy

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

  4. incidence of chest congestion

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

  5. fetal arterial partial pressure of oxygen

    Time frame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  6. arterial base excess of fetal arterial blood

    Time frame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  7. lowest neonatal cerebral oxygen saturation

    Time frame: from clamp of the umbilical cord to 10 min later, 10min in total

  8. lactate level of fetal arterial blood

    Time frame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery

  9. number of rescue vasoactive agent

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

  10. incidence of bradycardia

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

  11. incidence of dyspnea

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

  12. Apgar scores of the neonates

    Time frame: from clamp of umbilical cord to 1min 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

  13. Apgar scores of the neonates

    Time frame: from 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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2015
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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