Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
Primary Purpose
Adverse Effect
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Normal saline
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Adverse Effect focused on measuring Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Control group
0.3125 μg/kg/min group
0.625 μg/kg/min group
0.9375 μg/kg/min group
Arm Description
Normal saline infusion simultaneous with subarachnoid block
A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block
A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block
A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block
Outcomes
Primary Outcome Measures
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) < 80% of the baseline
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 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
From umbilical arterial blood gases.
Base excess
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
NCT04576663
First Posted
September 30, 2020
Last Updated
November 25, 2021
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04576663
Brief Title
Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
Official Title
Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 21, 2025 (Anticipated)
Study Completion Date
September 21, 2025 (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 suitable infusion dose of phenylephrine 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section, Dose-finding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline infusion simultaneous with subarachnoid block
Arm Title
0.3125 μg/kg/min group
Arm Type
Experimental
Arm Description
A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block
Arm Title
0.625 μg/kg/min group
Arm Type
Experimental
Arm Description
A maintenance dose of phenylephrine (0.625 μg/kg/ min) infusion simultaneous with subarachnoid block
Arm Title
0.9375 μg/kg/min group
Arm Type
Experimental
Arm Description
A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
Normal saline infusion simultaneous with subarachnoid block
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
Different infusion dose of phenylephrine simultaneous with subarachnoid block
Primary Outcome Measure Information:
Title
The incidence of post-spinal anesthesia hypotension
Description
Systolic blood pressure (SBP) < 80% of the baseline
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
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 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 bradycardia
Description
Heart rate < 60 beats/min
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
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
Xinli Ni, Dr.
Phone
86-951-674-3252
Email
xinlini6@nyfy.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Chen, M.D.
Phone
86-951-674-3252
Email
czzyxgp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinli Ni, Dr.
Organizational Affiliation
Hospital of Ningxia Medical University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phenylephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
We'll reach out to this number within 24 hrs