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NCT Number: NCT04272632

Coload Optimization Guided by Inferior Vena Cava Collapsibility Index

The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

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Key information

Conditions

Age range

18 year–40 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 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. However, our study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of coload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal coload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

4 ml/kg group

Drug

4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Other names: Crystalloid

8 ml/kg group

Drug

8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Other names: Crystalloid

12 ml/kg group

Drug

12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Other names: Crystalloid

Primary outcomes

  1. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    Time frame: Baseline (before preload)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

  2. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    Time frame: Before spinal anesthesia (after preload)

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

  3. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    Time frame: 5 min after spinal anesthesia

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

  4. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    Time frame: 5 min after fetal delivery

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

  5. The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    Time frame: Before leaving the operating room

    IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]

Secondary outcomes

  1. The incidence of post-spinal anesthesia hypotension.

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) < 80% of the baseline.

  2. The incidence of severe post-spinal anesthesia hypotension.

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) < 60% of the baseline

  3. The incidence of nausea and vomiting.

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  4. The incidence of bradycardia

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 55 beats/min.

  5. The incidence of hypertension

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) >120% of the baseline

  6. pH

    Time frame: Immediately after delivery

    From umbilical vein blood gases

  7. Partial pressure of oxygen

    Time frame: Immediately after delivery

    From umbilical vein blood gases

  8. Base excess

    Time frame: Immediately after delivery

    From umbilical vein blood gases

  9. APGAR score

    Time frame: 1min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  10. APGAR score

    Time frame: 5min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  11. Overall stability of systolic blood pressure control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia.

    Evaluated by performance error (PE).

  12. Overall stability of heart rate control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia.

    Evaluated by performance error (PE).

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Coload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Nov 29, 2021

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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