Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508359
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section A Multicenter Single-blind Crossover Factorial Cluster Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to explore the effects of different application modes prophylactic and rescue strategy of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section
Detailed Description:
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section The incidence of spinal anesthesia-induced hypotension is as high as 621-897 if prophylactic measures are not taken The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors specifically alpha-receptor agonists as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section compared to rescue strategy However it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence Therefore this study aims to explore the effects of different application modes prophylactic and rescue strategy of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter single-blind 22 crossover and cluster randomized trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None