Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics
Study Details
Study Description
Brief Summary
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 maternal hemodynamics following cesarean section.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard group 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
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 Names:
|
| Experimental: Intensive group 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
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cardiac output [1-15 minutes after spinal anesthesia.]
Monitoring data
- Cardiac index [1-15 minutes after spinal anesthesia.]
Monitoring data
- Stroke volume variation [1-15 minutes after spinal anesthesia.]
Monitoring data
- Peripheral vascular resistance [1-15 minutes after spinal anesthesia.]
Monitoring data
Secondary Outcome Measures
- The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) < 80% of the baseline
- The incidence of severe post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) < 60% of the baseline.
- The incidence of bradycardia. [1-15 minutes after spinal anesthesia.]
Heart rate < 60 beats/min.
- The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia.]
Presence of nausea and vomiting in patients after spinal anesthesia
- The incidence of hypertension. [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) >120% of the baseline.
- pH [Immediately after delivery]
From umbilical arterial blood gases.
- Base excess [Immediately after delivery]
From umbilical arterial blood gases.
- Partial pressure of oxygen (PO2) [Immediately after delivery]
From umbilical arterial blood gases.
- APGAR score [1 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
- APGAR score [5 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-45 years
-
Primipara or multipara
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Singleton pregnancy ≥37 weeks
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American Society of Anesthesiologists physical status classification I to II
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Scheduled for cesarean section under spinal anesthesia
Exclusion Criteria:
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Body height < 150 cm
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Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
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Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
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Hemoglobin < 7g/dl
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Fetal distress, or known fetal developmental anomaly
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- General Hospital of Ningxia Medical University
Investigators
- Study Chair: Xinli Ni, Ph.D, General Hospital of Ningxia Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Yi Chen-2024-2