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出境医 / 临床实验 / Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index

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

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).

Condition or disease Intervention/treatment Phase
Adverse Effect Drug: normal saline Drug: Norepinephrine Not Applicable

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).
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Normal saline
Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
 Drug: normal saline
a bolus of normal saline was given followed by normal saline infusion
Other Name: NS
Experimental: Norepinephrine
Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion
 Drug: Norepinephrine
a bolus of norepinephrine was given followed by norepinephrine infusion
Other Name: Vasopressors
Outcome Measures
Primary Outcome Measures :
  1. The incidence of hypotension [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    SBP decreased to <80% of the baseline value

  2. Inferior vena cava collapsibility index [ Time Frame: 5 to 20 minutes after subarachnoid block ]
    CI = (dIVCmax - dIVCmin)/dIVCmax


Secondary Outcome Measures :
  1. The incidence of nausea and vomiting [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Presence of nausea and vomiting in patients after subarachnoid block

  2. The incidence of bradycardia [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Heart rate less than 55 bpm

  3. Incidence of hypertension [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Systolic blood pressure at or above 120% of baseline

  4. Arterial base excess of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases

  5. Pressure of oxygen of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases

  6. pH value of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases

  7. Number of rescue norepinephrine [ Time Frame: Immediately to 20 minutes after subarachnoid block ]
    a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value

  8. APGAR score [ Time Frame: 1min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  9. APGAR score [ Time Frame: 5min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  10. APGAR score [ Time Frame: 10min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Ningxia
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Chair: Xinli Ni, Dr. xinlini6@yahoo.com
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • The incidence of hypotension [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    SBP decreased to <80% of the baseline value
  • Inferior vena cava collapsibility index [ Time Frame: 5 to 20 minutes after subarachnoid block ]
    CI = (dIVCmax - dIVCmin)/dIVCmax
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • The incidence of nausea and vomiting [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Presence of nausea and vomiting in patients after subarachnoid block
  • The incidence of bradycardia [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Heart rate less than 55 bpm
  • Incidence of hypertension [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Systolic blood pressure at or above 120% of baseline
  • Arterial base excess of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • Pressure of oxygen of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • pH value of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • Number of rescue norepinephrine [ Time Frame: Immediately to 20 minutes after subarachnoid block ]
    a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value
  • APGAR score [ Time Frame: 1min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
  • APGAR score [ Time Frame: 5min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
  • APGAR score [ Time Frame: 10min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • The incidence of nausea and vomiting [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Presence of nausea and vomiting in patients after subarachnoid block
  • The incidence of bradycardia [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Heart rate less than 55 bpm
  • APGAR score [ Time Frame: 1min、5min and 10min after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
  • Incidence of hypertension [ Time Frame: 1 to 20 minutes after subarachnoid block ]
    Systolic blood pressure at or above 120% of baseline
  • Arterial base excess of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • Pressure of oxygen of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • pH value of fetal vein blood [ Time Frame: Immediately after delivery ]
    From umbilical vein blood gases
  • Number of rescue norepinephrine [ Time Frame: Immediately to 20 minutes after subarachnoid block ]
    a bolus of norepinephrine was given when SBP decreased to <80% of the baseline value
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index
Official Title  ICMJE Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adverse Effect
Intervention  ICMJE
  • Drug: normal saline
    a bolus of normal saline was given followed by normal saline infusion
    Other Name: NS
  • Drug: Norepinephrine
    a bolus of norepinephrine was given followed by norepinephrine infusion
    Other Name: Vasopressors
Study Arms  ICMJE
  • Placebo Comparator: Normal saline
    Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
    Intervention: Drug: normal saline
  • Experimental: Norepinephrine
    Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion
    Intervention: Drug: Norepinephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2020) 		195
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2019) 		200
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997500
Other Study ID Numbers  ICMJE Yi Chen
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party General Hospital of Ningxia Medical University
Study Sponsor  ICMJE General Hospital of Ningxia Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xinli Ni, Dr. xinlini6@yahoo.com
PRS Account General Hospital of Ningxia Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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