Preload Optimization Guided by Inferior Vena Cava Collapsibility Index

Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272580
• Other study ID #: Yi Chen-2020-2
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 27, 2021

Study information

• Verified date: February 2020
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. However, the investigator's 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 preload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: March 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect

Intervention

Drug:
• Control group
No preload was given before spinal anesthesia.
• 4 ml/kg group.
4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
• 8 ml/kg group.
8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
• 12 ml/kg group.
12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]	Baseline (before preload)
Primary	The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]	Before spinal anesthesia (after preload)
Primary	The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]	5 min after spinal anesthesia
Primary	The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]	5 min after fetal delivery
Primary	The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	IVC-CI = [(IVC-max-IVC-min) /IVC-max*100%]	Before leaving the operating room
Secondary	The incidence of post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 80% of the baseline.	1-15 minutes after spinal anesthesia
Secondary	The incidence of severe post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 60% of the baseline	1-15 minutes after spinal anesthesia.
Secondary	The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia.
Secondary	The incidence of bradycardia	Heart rate < 55 beats/min.	1-15 minutes after spinal anesthesia
Secondary	The incidence of hypertension	Systolic blood pressure (SBP) >120% of the baseline	1-15 minutes after spinal anesthesia
Secondary	pH	From umbilical arterial blood gases	Immediately after delivery
Secondary	Partial pressure of oxygen	From umbilical arterial blood gases	Immediately after delivery
Secondary	Base excess	From umbilical arterial blood gases	Immediately after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	1min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	5min after delivery
Secondary	Overall stability of systolic blood pressure control versus baseline	Evaluated by performance error (PE).	1-15 minutes after spinal anesthesia.
Secondary	Overall stability of heart rate control versus baseline	Evaluated by performance error (PE).	1-15 minutes after spinal anesthesia.