NCT04272580

Preload Optimization Guided by Inferior Vena Cava Collapsibility Index

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: General Hospital of Ningxia Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adverse Effect

Interventions

Type	Name	Description
DRUG	Control group	No preload was given before 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 before 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 before 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 before spinal anesthesia.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-03-27
• Completion: 2021-03-27
• First posted: 2020-02-17
• Last updated: 2021-07-06

Locations

1 site across 1 country: China