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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Primary Purpose

Adverse Effect

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Norepinephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Criteria: Inclusion Criteria:

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥32 weeks
  • American Society of Anesthesiologists physical status classification II to III
  • Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

  • Baseline blood pressure ≥180 mmHg
  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Norepinephrine group

Arm Description

Phenylephrine infusion simultaneous with subarachnoid block

Norepinephrine infusion simultaneous with subarachnoid block

Outcomes

Primary Outcome Measures

The incidence of bradycardia
Heart rate < 60 beats/min

Secondary Outcome Measures

Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)

Full Information

First Posted
September 15, 2020
Last Updated
November 25, 2021
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04556357
Brief Title
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
Official Title
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Detailed Description
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Norepinephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Phenylephrine infusion simultaneous with subarachnoid block
Arm Title
Norepinephrine group
Arm Type
Experimental
Arm Description
Norepinephrine infusion simultaneous with subarachnoid block
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Primary Outcome Measure Information:
Title
The incidence of bradycardia
Description
Heart rate < 60 beats/min
Time Frame
1-15 minutes after spinal anesthesia.
Secondary Outcome Measure Information:
Title
Overall stability of systolic blood pressure control versus baseline
Description
Evaluated by performance error (PE)
Time Frame
1-15 minutes after spinal anesthesia
Other Pre-specified Outcome Measures:
Title
Overall stability of heart rate control versus baseline
Description
Evaluated by performance error (PE)
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of postspinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 80% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of severe post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 60% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of nausea and vomiting.
Description
Presence of nausea and vomiting in patients after spinal anesthesia
Time Frame
1-15 minutes after spinal anesthesia
Title
The incidence of hypertension
Description
Systolic blood pressure (SBP) >120% of the baseline.
Time Frame
1-15 minutes after spinal anesthesia
Title
pH
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Partial pressure of oxygen
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Base excess
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
1 min after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
5 min after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion Criteria: 18-45 years Primipara or multipara Singleton pregnancy ≥32 weeks American Society of Anesthesiologists physical status classification II to III Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: Baseline blood pressure ≥180 mmHg Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinli Ni, Dr.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

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