NCT06151431

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension in Preeclamptic Patients

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes in Preeclamptic Patients During Cesarean Section

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: General Hospital of Ningxia Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following 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. 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 post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes in preeclamptic patients following cesarean section.

Conditions

• Adverse Effect

Interventions

Type	Name	Description
DRUG	Alpha-Agonist	The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
DRUG	α-adrenergic receptor agonist	The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-11-30
• Last updated: 2023-12-15

Locations

1 site across 1 country: China