Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
Primary Purpose
Hemodynamic Instability
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Hemodynamic Instability focused on measuring Cardiac output response, Norepinephrine, Phenylephrine, Preeclampsia, Cesarean section
Eligibility 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 UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Phenylephrine group
Norepinephrine group
Arm Description
Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred
Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred
Outcomes
Primary Outcome Measures
Cardiac output (CO)
Evaluated by the VIGILCO monitoring system.
Stroke volume (SV)
Evaluated by the VIGILCO monitoring system.
Systemic vascular resistance (SVR)
Evaluated by the VIGILCO monitoring system.
Secondary Outcome Measures
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE)
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) < 60% of the baseline
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of bradycardia.
Heart rate < 60 beats/min.
The incidence of hypertension.
Systolic blood pressure (SBP) >120% of the baseline.
pH
From umbilical arterial blood gases.
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Base excess (BE)
From umbilical arterial blood gases.
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Full Information
NCT ID
NCT05035485
First Posted
September 2, 2021
Last Updated
February 27, 2023
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05035485
Brief Title
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
Official Title
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses During Spinal Anesthesia for Caesarean Section in Patients With Severe Preeclampsia: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
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 maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for 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. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal 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
Hemodynamic Instability
Keywords
Cardiac output response, Norepinephrine, Phenylephrine, Preeclampsia, Cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine group
Arm Type
Active Comparator
Arm Description
Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred
Arm Title
Norepinephrine group
Arm Type
Experimental
Arm Description
Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
Primary Outcome Measure Information:
Title
Cardiac output (CO)
Description
Evaluated by the VIGILCO monitoring system.
Time Frame
1-30 minutes after spinal anesthesia.
Title
Stroke volume (SV)
Description
Evaluated by the VIGILCO monitoring system.
Time Frame
1-30 minutes after spinal anesthesia
Title
Systemic vascular resistance (SVR)
Description
Evaluated by the VIGILCO monitoring system.
Time Frame
1-30 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
1-30 minutes after spinal anesthesia
Title
Overall stability of heart rate control versus baseline
Description
Evaluated by performance error (PE)
Time Frame
1-30 minutes after spinal anesthesia
Title
The incidence of post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 80% of the baseline
Time Frame
1-30 minutes after spinal anesthesia.
Title
The incidence of severe post-spinal anesthesia hypotension.
Description
Systolic blood pressure (SBP) < 60% of the baseline
Time Frame
1-30 minutes after spinal anesthesia.
Title
The incidence of nausea and vomiting.
Description
Presence of nausea and vomiting in patients after spinal anesthesia
Time Frame
1-30 minutes after spinal anesthesia
Title
The incidence of bradycardia.
Description
Heart rate < 60 beats/min.
Time Frame
1-30 minutes after spinal anesthesia
Title
The incidence of hypertension.
Description
Systolic blood pressure (SBP) >120% of the baseline.
Time Frame
1-30 minutes after spinal anesthesia
Title
pH
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Partial pressure of oxygen (PO2)
Description
From umbilical arterial blood gases.
Time Frame
Immediately after delivery
Title
Base excess (BE)
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Chen, M.D.
Phone
86-951-674-3252
Email
czzyxgp@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangzhao Xu, M.D.; Ph. D
Email
xxz0311@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Chen, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiangzhao Xu, M.D.; Ph. D
Organizational Affiliation
The People's Hospital of Nanchuan
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Chen, M.D.
Email
czzyxgp@163.com
12. IPD Sharing Statement
Learn more about this trial
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
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