NCT06158009

ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment

ED90 of Norepinephrine and Phenylephrine Boluses for Treating Postspinal Anesthesia Hypotension Under Intensive Treatment During Cesarean Section

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (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 ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment during 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 ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment during cesarean section

Conditions

• Adverse Effect

Interventions

Type	Name	Description
DRUG	Norepinephrine	An initial infusion dose of prophylactic norepinephrine (6 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 ug of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
DRUG	Phenylephrine	An initial infusion dose of prophylactic phenylephrine (75 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 12.5 ug of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-12-06
• Last updated: 2023-12-06