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Phenylephrine 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04576663
Recruitment Status : Not yet recruiting
First Posted : October 6, 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 suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Condition or disease Intervention/treatment Phase
Adverse Effect Drug: Normal saline Drug: Phenylephrine 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. Practical guidelines for obstetric anesthesia from the American Society of Anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either IV ephedrine or phenylephrine may be used to correct hypotension. But the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of phenylephrine 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)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : September 21, 2025
Estimated Study Completion Date : September 21, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
Normal saline infusion simultaneous with subarachnoid block
 Drug: Normal saline
Normal saline infusion simultaneous with subarachnoid block
Other Name: NS
Experimental: 0.3125 μg/kg/min group
A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block
 Drug: Phenylephrine
Different infusion dose of phenylephrine simultaneous with subarachnoid block
Other Name: Vasopressors
Experimental: 0.625 μg/kg/min group
A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block
 Drug: Phenylephrine
Different infusion dose of phenylephrine simultaneous with subarachnoid block
Other Name: Vasopressors
Experimental: 0.9375 μg/kg/min group
A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block
 Drug: Phenylephrine
Different infusion dose of phenylephrine simultaneous with subarachnoid block
Other Name: Vasopressors


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


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)

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

  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 bradycardia [ Time Frame: 1-15 minutes after spinal anesthesia ]
    Heart rate < 60 beats/min

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

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

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

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

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

  11. 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

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): NCT04576663


Contacts
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Contact: Xinli Ni, Dr. 86-951-674-3252 xinlini6@nyfy.com.cn
Contact: Yi Chen, M.D. 86-951-674-3252 czzyxgp@163.com

Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Chair: Xinli Ni, Dr. 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: NCT04576663    
Other Study ID Numbers: Yi Chen-2020-6
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: September 2021

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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:
Phenylephrine
Postspinal anesthesia hypotension
Preeclampsia
Cesarean section
Dose-finding
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypotension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
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