Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension

Outcome Clinical Trial

Official title:

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal and Neonatal Outcomes During Cesarean Section: A Multicenter, Prospective, Single-blind, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151483
• Other study ID #: Yi Chen-2024-1
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: General Hospital of Ningxia Medical University
• Contact: Yi Chen, M.D.
• Phone: +86-0951-6743252
• Email: czzyxgp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on neonatal outcomes following cesarean section.

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 following cesarean section.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Criteria: Inclusion Criteria:

• 18-45 years

• Primipara or multipara

• Singleton pregnancy =37 weeks

• American Society of Anesthesiologists physical status classification I to II

• Scheduled for 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 =180 mmHg

• Hemoglobin < 7g/dl

• Fetal distress, or known fetal developmental anomaly

Related Conditions & MeSH terms

• Hypotension
• Outcome

Intervention

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.

Other:
• a-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.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH	From umbilical arterial blood gases.	Immediately after delivery
Primary	Base excess	From umbilical arterial blood gases.	Immediately after delivery
Secondary	The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-15 minutes after spinal anesthesia
Secondary	The incidence of severe post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 60% of the baseline.	1-15 minutes after spinal anesthesia
Secondary	The incidence of bradycardia.	Heart rate < 50 beats/min.	1-15 minutes after spinal anesthesia
Secondary	The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-15 minutes after spinal anesthesia
Secondary	The incidence of hypertension.	Systolic blood pressure (SBP) >120% of the baseline.	1-15 minutes after spinal anesthesia
Secondary	Partial pressure of oxygen (PO2)	From umbilical arterial blood gases.	Immediately after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)	1 min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)	5 min after delivery