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Completed

NCT Number: NCT03997500

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

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

a bolus of normal saline was given followed by normal saline infusion

Other names: NS

norepinephrine

Drug

a bolus of norepinephrine was given followed by norepinephrine infusion

Other names: Vasopressors

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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