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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adverse Effect

Intervention / Treatment
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* Drug: Alpha-Agonist
* Drug: α-adrenergic receptor agonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years Primipara or multipara Singleton pregnancy ≥32 weeks American Society of Anesthesiologists physical status classification I to III Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: Baseline blood pressure ≥160 mmHg Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard group<br>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: Alpha-Agonist<br>* The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.<br>* Other names: Vasopressors;|
| Experimental: Intensive group<br>The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. | Drug: α-adrenergic receptor agonist<br>* The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.<br>* Other names: Vasopressors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH | From umbilical arterial blood gases. | Immediately after delivery | 
| Base excess | From umbilical arterial blood gases. | Immediately after delivery | 

Secondary Outcome Measures

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