Preload Optimization Guided by Inferior Vena Cava Collapsibility Index

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: Control group; Drug: 12 ml/kg group.; Drug: 8 ml/kg group.; Drug: 4 ml/kg group.

• Registration Number: NCT04272580
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-07-01
• Primary Completion: 2021-03-27
• Study Completion: 2021-03-27
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	No preload was given before spinal anesthesia
12 ml/kg group	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.
8 ml/kg group	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.
4 ml/kg group	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

Primary Outcome Measures

Name	Time	Method
The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)	Before leaving the operating room	IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

Secondary Outcome Measures

Name	Time	Method
Base excess	Immediately after delivery	From umbilical arterial blood gases
The incidence of post-spinal anesthesia hypotension.	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \< 80% of the baseline.
The incidence of severe post-spinal anesthesia hypotension.	1-15 minutes after spinal anesthesia.	Systolic blood pressure (SBP) \< 60% of the baseline
pH	Immediately after delivery	From umbilical arterial blood gases
Overall stability of heart rate control versus baseline	1-15 minutes after spinal anesthesia.	Evaluated by performance error (PE).
The incidence of nausea and vomiting.	1-15 minutes after spinal anesthesia.	Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of hypertension	1-15 minutes after spinal anesthesia	Systolic blood pressure (SBP) \>120% of the baseline
Partial pressure of oxygen	Immediately after delivery	From umbilical arterial blood gases
Overall stability of systolic blood pressure control versus baseline	1-15 minutes after spinal anesthesia.	Evaluated by performance error (PE).
The incidence of bradycardia	1-15 minutes after spinal anesthesia	Heart rate \< 55 beats/min.
APGAR score	5min after delivery	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China