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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Completed
CT.gov ID
NCT02542748
Collaborator
(none)
66
1
2
7.9
8.4

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study
Actual Study Start Date :
Oct 5, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: norepinephrine

norepinephrine is injected after spinal anesthesia

Drug: Norepinephrine
norepinephrine injection
Other Names:
  • vasoactive agents
  • Other: ephedrine

    ephedrine is injected after spinal anesthesia

    Drug: Ephedrine
    Ephedrine injection
    Other Names:
  • vasoactive agents
  • Outcome Measures

    Primary Outcome Measures

    1. incidence of hypotension [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    Secondary Outcome Measures

    1. pH value of fetal arterial blood [just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery]

    2. incidence of nausea and vomiting [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    3. incidence of dizzy [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    4. incidence of chest congestion [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    5. fetal arterial partial pressure of oxygen [just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery]

    6. arterial base excess of fetal arterial blood [just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery]

    7. lowest neonatal cerebral oxygen saturation [from clamp of the umbilical cord to 10 min later, 10min in total]

    8. lactate level of fetal arterial blood [just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery]

    9. number of rescue vasoactive agent [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    10. incidence of bradycardia [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    11. incidence of dyspnea [from immediately after spinal anesthesia to 30min after spinal anesthesia]

    12. Apgar scores of the neonates [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital,Fourth Military Medical University Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

    • Study Chair: Hailong DONG, Prof., Xijing Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhihong LU, Dr, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT02542748
    Other Study ID Numbers:
    • XJH-A-2015-5-5-01
    First Posted:
    Sep 7, 2015
    Last Update Posted:
    Jan 15, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Zhihong LU, Dr, Air Force Military Medical University, China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 15, 2019