The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
Primary Purpose
Adverse Effect
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Adverse Effect focused on measuring Norepinephrine, Phenylephrine, Postspinal anesthesia hypotension, 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Phenylephrine group
Norepinephrine group
Arm Description
Prophylactic phenylephrine bolus simultaneous with spinal anesthesia
Prophylactic norepinephrine bolus simultaneous with spinal anesthesia
Outcomes
Primary Outcome Measures
The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
Systolic blood pressure (SBP) < 80% of the baseline
Secondary Outcome Measures
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 bradycardia.
Heart rate < 60 beats/min.
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
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
NCT05035472
First Posted
September 2, 2021
Last Updated
September 5, 2021
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05035472
Brief Title
The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
Official Title
Comparison of the Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients With Severe Preeclampsia During Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
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 potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.
Detailed Description
Preeclampsia, which affects 5% to 7% of patients, 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 patients with preeclampsia are apparently higher than healthy patients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in patients with preeclampsia for cesarean section. In preeclampsia patients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% patients 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 patients undergoing cesarean section. However, the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus is still unknown. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Norepinephrine, Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenylephrine group
Arm Type
Active Comparator
Arm Description
Prophylactic phenylephrine bolus simultaneous with spinal anesthesia
Arm Title
Norepinephrine group
Arm Type
Experimental
Arm Description
Prophylactic norepinephrine bolus simultaneous with spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.
Primary Outcome Measure Information:
Title
The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
Description
Systolic blood pressure (SBP) < 80% of the baseline
Time Frame
1-15 minutes after spinal anesthesia
Secondary 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
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 bradycardia.
Description
Heart rate < 60 beats/min.
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 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 (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
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
General Hospital of Ningxia Medical University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
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