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Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Primary Purpose

Adverse Effect

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Effect focused on measuring Norepinephrine, Phenylephrine, Postspinal anesthesia hypotension, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Sites / Locations

  • General Hospital of Ningxia Medical University

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

First Posted
September 3, 2021
Last Updated
January 4, 2023
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05035888
Brief Title
Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
Official Title
Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

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 undergoing caesarean section.
Detailed Description
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing 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, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

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 ≥37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly
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
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China

12. IPD Sharing Statement

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Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

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