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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556357
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adverse Effect Drug: Phenylephrine Drug: Norepinephrine Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial
Actual Study Start Date : September 22, 2020
Actual Primary Completion Date : November 15, 2021
Actual Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control group
Phenylephrine infusion simultaneous with subarachnoid block
 Drug: Phenylephrine
A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
Other Name: Vasopressors
Experimental: Norepinephrine group
Norepinephrine infusion simultaneous with subarachnoid block
 Drug: Norepinephrine
A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Other Name: Vasopressors


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of bradycardia [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Heart rate < 60 beats/min


Secondary Outcome Measures :
  1. Overall stability of systolic blood pressure control versus baseline [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Evaluated by performance error (PE)


Other Outcome Measures:
  1. Overall stability of heart rate control versus baseline [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Evaluated by performance error (PE)

  2. The incidence of postspinal anesthesia hypotension [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Systolic blood pressure (SBP) < 80% of the baseline

  3. The incidence of severe post-spinal anesthesia hypotension [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Systolic blood pressure (SBP) < 60% of the baseline

  4. The incidence of nausea and vomiting. [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of hypertension [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Systolic blood pressure (SBP) >120% of the baseline.

  6. pH [ Time Frame: Immediately after delivery ]
    From umbilical arterial blood gases.

  7. Partial pressure of oxygen [ Time Frame: Immediately after delivery ]
    From umbilical arterial blood gases.

  8. Base excess [ Time Frame: Immediately after delivery ]
    From umbilical arterial blood gases.

  9. APGAR score [ Time Frame: 1 min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  10. APGAR score [ Time Frame: 5 min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556357


Locations
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China, Ningxia
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Chair: Xinli Ni, Dr. General Hospital of Ningxia Medical University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT04556357    
Other Study ID Numbers: Yi Chen-2020-4
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by General Hospital of Ningxia Medical University:
Norepinephrine
Postspinal anesthesia hypotension
Preeclampsia
Cesarean section
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypotension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Phenylephrine
Oxymetazoline
Norepinephrine
Vasoconstrictor Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents