Preload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial
Overview
- Phase
- Not Applicable
- Intervention
- Control group
- Conditions
- Adverse Effect
- Sponsor
- General Hospital of Ningxia Medical University
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Control group
No preload was given before spinal anesthesia
Intervention: Control 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
Intervention: 4 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.
Intervention: 8 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.
Intervention: 12 ml/kg group.
Outcomes
Primary Outcomes
The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
Time Frame: Before leaving the operating room
IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]
Secondary Outcomes
- The incidence of post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia.)
- pH(Immediately after delivery)
- Overall stability of heart rate control versus baseline(1-15 minutes after spinal anesthesia.)
- Base excess(Immediately after delivery)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)
- The incidence of hypertension(1-15 minutes after spinal anesthesia)
- Partial pressure of oxygen(Immediately after delivery)
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia.)
- The incidence of bradycardia(1-15 minutes after spinal anesthesia)
- APGAR score(5min after delivery)