- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05035498
Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia
January 31, 2024 updated by: General Hospital of Ningxia Medical University
Comparison of Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia During Cesarean Section: a Randomized, Controlled Trial
The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
However, hemodynamic effects of the prophylactic norepinephrine infusion is still unknown.
The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Chen, M.D.
- Phone Number: 86-951-674-3252
- Email: czzyxgp@163.com
Study Contact Backup
- Name: Xinli Ni, Dr.
- Phone Number: 86-951-674-3252
- Email: xinlini6@nyfy.com.cn
Study Locations
-
-
Ningxia
-
Yinchuan, Ningxia, China, 750004
- Recruiting
- General Hospital of Ningxia Medical University
-
Contact:
- Yi Chen, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Phenylephrine group
Phenylephrine infusion simultaneous with spinal anesthesia
|
A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
Other Names:
|
Experimental: Norepinephrine group
Norepinephrine infusion simultaneous with spinal anesthesia
|
A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output (CO)
Time Frame: 1-30 minutes after spinal anesthesia
|
Evaluated by the VIGILCO monitoring system
|
1-30 minutes after spinal anesthesia
|
Stroke volume (SV)
Time Frame: 1-30 minutes after spinal anesthesia
|
Evaluated by the VIGILCO monitoring system
|
1-30 minutes after spinal anesthesia
|
Systemic vascular resistance (SVR)
Time Frame: 1-30 minutes after spinal anesthesia
|
Evaluated by the VIGILCO monitoring system
|
1-30 minutes after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pH
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
APGAR score
Time Frame: 1 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
|
1 min after delivery
|
APGAR score
Time Frame: 5 min after delivery
|
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
|
5 min after delivery
|
Partial pressure of oxygen (PO2)
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
Base excess (BE)
Time Frame: Immediately after delivery
|
From umbilical arterial blood gases.
|
Immediately after delivery
|
Overall stability of systolic blood pressure control versus baseline
Time Frame: 1-30 minutes after spinal anesthesia
|
Evaluated by performance error (PE)
|
1-30 minutes after spinal anesthesia
|
Overall stability of heart rate control versus baseline
Time Frame: 1-30 minutes after spinal anesthesia
|
Evaluated by performance error (PE)
|
1-30 minutes after spinal anesthesia
|
The incidence of post-spinal anesthesia hypotension
Time Frame: 1-30 minutes after spinal anesthesia.
|
Systolic blood pressure (SBP) < 80% of the baseline
|
1-30 minutes after spinal anesthesia.
|
The incidence of severe post-spinal anesthesia hypotension.
Time Frame: 1-30 minutes after spinal anesthesia.
|
Systolic blood pressure (SBP) < 60% of the baseline
|
1-30 minutes after spinal anesthesia.
|
The incidence of nausea and vomiting.
Time Frame: 1-30 minutes after spinal anesthesia
|
Presence of nausea and vomiting in patients after spinal anesthesia
|
1-30 minutes after spinal anesthesia
|
The incidence of bradycardia.
Time Frame: 1-30 minutes after spinal anesthesia
|
Heart rate < 60 beats/min.
|
1-30 minutes after spinal anesthesia
|
The incidence of hypertension.
Time Frame: 1-30 minutes after spinal anesthesia
|
Systolic blood pressure (SBP) >120% of the baseline.
|
1-30 minutes after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xinli Ni, Dr., General Hospital of Ningxia Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Estimated)
April 21, 2025
Study Completion (Estimated)
April 21, 2025
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
September 2, 2021
First Posted (Actual)
September 5, 2021
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Pre-Eclampsia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Norepinephrine
- Phenylephrine
- Oxymetazoline
- Vasoconstrictor Agents
Other Study ID Numbers
- Yi Chen-2021-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodynamic Instability
-
Johannes Gutenberg University MainzRecruiting
-
Cairo UniversityRecruitingHemodynamic InstabilityEgypt
-
Johannes Gutenberg University MainzRecruitingHemodynamic InstabilityGermany
-
Chaudhry Pervaiz Elahi Institute of CardiologyRecruitingHemodynamic InstabilityPakistan
-
University of MonastirCompleted
-
Mansoura UniversityCompleted
-
University of British ColumbiaCompletedHemodynamic InstabilityCanada
-
Inonu UniversityCompletedHemodynamic InstabilityTurkey
-
Muhammad Haroon AnwarPakistan Institute of Medical SciencesRecruiting
-
Sykehuset TelemarkUniversity of Oslo; Oslo University HospitalCompleted
Clinical Trials on Phenylephrine
-
Cairo UniversityUnknownCesarean Section Complications | Spinal AnesthesiaEgypt
-
Sun Yat-sen UniversityRecruitingPancreatic CancerChina
-
The University of Texas at ArlingtonCompletedCardiovascular Diseases | Cardiovascular Risk Factor | VasoconstrictionUnited States
-
Montefiore Medical CenterCompletedCough Reflex SensitivityUnited States
-
Eyenovia Inc.Completed
-
Rabin Medical CenterCompletedInfection in Solid Organ Transplant RecipientsIsrael
-
Cairo UniversityCompletedCesarean Section Complications | Spinal AnesthesiaEgypt
-
IWK Health CentreDuke UniversityCompletedHypotensionUnited States, Canada
-
University of the PhilippinesCompleted
-
BioLineRx, Ltd.Completed