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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

Primary Purpose

Adverse Effect

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

About this trial

This is an interventional prevention trial for Adverse Effect focused on measuring Norepinephrine, Hypotension, Cesarean section, Dose-finding

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-40 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective 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 ≥ 160mmHg
  • 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 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

0.025 μg/kg/min group

0.05 μg/kg/min group

0.075 μg/kg/min group

0.1 μg/kg/min group

Arm Description

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).

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 < 55 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

First Posted
February 11, 2020
Last Updated
July 31, 2020
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04272567
Brief Title
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension
Official Title
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (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 suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
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. Vasopressors 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. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Norepinephrine, Hypotension, Cesarean section, Dose-finding

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Arm Title
0.025 μg/kg/min group
Arm Type
Experimental
Arm Description
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).
Arm Title
0.05 μg/kg/min group
Arm Type
Experimental
Arm Description
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).
Arm Title
0.075 μg/kg/min group
Arm Type
Experimental
Arm Description
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).
Arm Title
0.1 μg/kg/min group
Arm Type
Experimental
Arm Description
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
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 < 55 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
1min after delivery
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
5min after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-40 years Primipara or multipara Singleton pregnancy ≥37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for elective 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 ≥ 160mmHg Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly
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
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

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