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Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

Primary Purpose

Adverse Effect

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
normal saline
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, Hypotension, Inferior Vena Cava Collapsibility Index, Cesarean Delivery

Eligibility Criteria

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

Inclusion Criteria:

  • 18-45 years
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean delivery under spinal anesthesia
  • Full-term, singleton, pregnant women

Exclusion Criteria:

  • Height of no more than 150 centimeters
  • Body weight greater than 100 kg or BMI greater than 30
  • Labor analgesia had been performed
  • Contraindication of spinal or epidural anesthesia
  • Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
  • Hemoglobin <7g/dl
  • Fetal distress or known abnormal fetal development
  • Severe vascular disease
  • Diabetes mellitus or cardiovascular disease or nervous system disease

Sites / Locations

  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal saline

Norepinephrine

Arm Description

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

Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion

Outcomes

Primary Outcome Measures

The incidence of hypotension
SBP decreased to <80% of the baseline value
Inferior vena cava collapsibility index
CI = (dIVCmax - dIVCmin)/dIVCmax

Secondary Outcome Measures

The incidence of nausea and vomiting
Presence of nausea and vomiting in patients after subarachnoid block
The incidence of bradycardia
Heart rate less than 55 bpm
Incidence of hypertension
Systolic blood pressure at or above 120% of baseline
Arterial base excess of fetal vein blood
From umbilical vein blood gases
Pressure of oxygen of fetal vein blood
From umbilical vein blood gases
pH value of fetal vein blood
From umbilical vein blood gases
Number of rescue norepinephrine
a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
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
May 28, 2019
Last Updated
February 13, 2020
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03997500
Brief Title
Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index
Official Title
Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
December 31, 2019 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).
Detailed Description
Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect
Keywords
Norepinephrine, Hypotension, Inferior Vena Cava Collapsibility Index, Cesarean Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
Arm Title
Norepinephrine
Arm Type
Experimental
Arm Description
Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
a bolus of normal saline was given followed by normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Vasopressors
Intervention Description
a bolus of norepinephrine was given followed by norepinephrine infusion
Primary Outcome Measure Information:
Title
The incidence of hypotension
Description
SBP decreased to <80% of the baseline value
Time Frame
1 to 20 minutes after subarachnoid block
Title
Inferior vena cava collapsibility index
Description
CI = (dIVCmax - dIVCmin)/dIVCmax
Time Frame
5 to 20 minutes after subarachnoid block
Secondary Outcome Measure Information:
Title
The incidence of nausea and vomiting
Description
Presence of nausea and vomiting in patients after subarachnoid block
Time Frame
1 to 20 minutes after subarachnoid block
Title
The incidence of bradycardia
Description
Heart rate less than 55 bpm
Time Frame
1 to 20 minutes after subarachnoid block
Title
Incidence of hypertension
Description
Systolic blood pressure at or above 120% of baseline
Time Frame
1 to 20 minutes after subarachnoid block
Title
Arterial base excess of fetal vein blood
Description
From umbilical vein blood gases
Time Frame
Immediately after delivery
Title
Pressure of oxygen of fetal vein blood
Description
From umbilical vein blood gases
Time Frame
Immediately after delivery
Title
pH value of fetal vein blood
Description
From umbilical vein blood gases
Time Frame
Immediately after delivery
Title
Number of rescue norepinephrine
Description
a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value
Time Frame
Immediately to 20 minutes after subarachnoid block
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
Title
APGAR score
Description
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time Frame
10min 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 American Society of Anesthesiologists physical status classification I to II Scheduled for elective cesarean delivery under spinal anesthesia Full-term, singleton, pregnant women Exclusion Criteria: Height of no more than 150 centimeters Body weight greater than 100 kg or BMI greater than 30 Labor analgesia had been performed Contraindication of spinal or epidural anesthesia Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg Hemoglobin <7g/dl Fetal distress or known abnormal fetal development Severe vascular disease Diabetes mellitus or cardiovascular disease or nervous system disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinli Ni, Dr.
Organizational Affiliation
xinlini6@yahoo.com
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

Plan to Share IPD
No

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Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

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