Coload Optimization Guided by Inferior Vena Cava Collapsibility Index

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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: 4 ml/kg group; Drug: 8 ml/kg group; Drug: 12 ml/kg group

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 4 ml/kg group; 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.	Drug: 4 ml/kg group; 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
EXPERIMENTAL: 8 ml/kg group; 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.	Drug: 8 ml/kg group; 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
EXPERIMENTAL: 12 ml/kg group; 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.	Drug: 12 ml/kg group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): November 25, 2021
• Study Completion (ACTUAL): November 25, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cesarean section; Norepinephrine; Coload; Dose-finding; Inferior vena cava collapsibility index
• Other Study ID Numbers: Yi Chen-2020-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No