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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 ml/kg group | Experimental | 4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia. |
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| 8 ml/kg group | Experimental | 8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia. |
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| 12 ml/kg group | Experimental | 12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-spinal anesthesia hypotension. | Systolic blood pressure (SBP) < 80% of the baseline. | 1-15 minutes after spinal anesthesia |
| The incidence of severe post-spinal anesthesia hypotension. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinli Ni, Dr. | General Hospital of Ningxia Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
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| 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. |
|
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| 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. |
|
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Systolic blood pressure (SBP) < 60% of the baseline
| 1-15 minutes after spinal anesthesia |
| 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 bradycardia | Heart rate < 55 beats/min. | 1-15 minutes after spinal anesthesia |
| The incidence of hypertension | Systolic blood pressure (SBP) >120% of the baseline | 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. |
| D004364 |
| Pharmaceutical Preparations |