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

Primary Purpose

Hypotension, Obstetrical Complication of Anesthesia, Complications; Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Norepinephrine
Ephedrine
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring norepinephrine, ephedrine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital,Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

norepinephrine

ephedrine

Arm Description

norepinephrine is injected after spinal anesthesia

ephedrine is injected after spinal anesthesia

Outcomes

Primary Outcome Measures

incidence of hypotension

Secondary Outcome Measures

pH value of fetal arterial blood
incidence of nausea and vomiting
incidence of dizzy
incidence of chest congestion
fetal arterial partial pressure of oxygen
arterial base excess of fetal arterial blood
lowest neonatal cerebral oxygen saturation
lactate level of fetal arterial blood
number of rescue vasoactive agent
incidence of bradycardia
incidence of dyspnea
Apgar scores of the neonates
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
Apgar scores of the neonates
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

Full Information

First Posted
September 3, 2015
Last Updated
January 12, 2019
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02542748
Brief Title
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients
Official Title
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Obstetrical Complication of Anesthesia, Complications; Cesarean Section
Keywords
norepinephrine, ephedrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine
Arm Type
Experimental
Arm Description
norepinephrine is injected after spinal anesthesia
Arm Title
ephedrine
Arm Type
Other
Arm Description
ephedrine is injected after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
vasoactive agents
Intervention Description
norepinephrine injection
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Other Intervention Name(s)
vasoactive agents
Intervention Description
Ephedrine injection
Primary Outcome Measure Information:
Title
incidence of hypotension
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Secondary Outcome Measure Information:
Title
pH value of fetal arterial blood
Time Frame
just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
Title
incidence of nausea and vomiting
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
incidence of dizzy
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
incidence of chest congestion
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
fetal arterial partial pressure of oxygen
Time Frame
just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
Title
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
Title
lowest neonatal cerebral oxygen saturation
Time Frame
from clamp of the umbilical cord to 10 min later, 10min in total
Title
lactate level of fetal arterial blood
Time Frame
just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
Title
number of rescue vasoactive agent
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
incidence of bradycardia
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
incidence of dyspnea
Time Frame
from immediately after spinal anesthesia to 30min after spinal anesthesia
Title
Apgar scores of the neonates
Description
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
Time Frame
from clamp of umbilical cord to 1min after clamping
Title
Apgar scores of the neonates
Description
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
Time Frame
from clamp of umbilical cord to 5min after clamping

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailong DONG, Prof.
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital,Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25654435
Citation
Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.
Results Reference
background
PubMed Identifier
25649721
Citation
Moslemi F, Rasooli S. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial. Iran J Med Sci. 2015 Jan;40(1):19-26.
Results Reference
background
PubMed Identifier
23793313
Citation
Mitra JK, Roy J, Bhattacharyya P, Yunus M, Lyngdoh NM. Changing trends in the management of hypotension following spinal anesthesia in cesarean section. J Postgrad Med. 2013 Apr-Jun;59(2):121-6. doi: 10.4103/0022-3859.113840.
Results Reference
background
PubMed Identifier
33661141
Citation
Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, Jiang XF, Wu ZX, Xiong LZ, Lu ZH. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021 Mar 4;134(7):792-799. doi: 10.1097/CM9.0000000000001404.
Results Reference
derived

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

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