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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
193
No preload was given before spinal anesthesia.
4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Time frame: Baseline (before preload)
The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Time frame: 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 = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Time frame: 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 = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Time frame: 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 = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Time frame: Before leaving the operating room
The incidence of post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) \< 80% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension.
Systolic blood pressure (SBP) \< 60% of the baseline
Time frame: 1-15 minutes after spinal anesthesia.
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12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
The incidence of nausea and vomiting.
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia.
The incidence of bradycardia
Heart rate \< 55 beats/min.
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Systolic blood pressure (SBP) \>120% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
pH
From umbilical arterial blood gases
Time frame: Immediately after delivery
Partial pressure of oxygen
From umbilical arterial blood gases
Time frame: Immediately after delivery
Base excess
From umbilical arterial blood gases
Time frame: Immediately after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 1min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5min after delivery
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE).
Time frame: 1-15 minutes after spinal anesthesia.
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE).
Time frame: 1-15 minutes after spinal anesthesia.