Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics in Preeclamptic Patients During Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Primary Endpoint
- Cardiac index
Study Overview
Brief Summary
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics 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 maternal hemodynamics in preeclamptic patients following cesarean section.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Alpha-Agonist (Drug)
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.
Intervention: α-adrenergic receptor agonist (Drug)
Outcomes
Primary Outcomes
Cardiac index
Time Frame: 1-15 minutes after spinal anesthesia.
Monitoring data
Cardiac output
Time Frame: 1-15 minutes after spinal anesthesia.
Monitoring data
Stroke volume variation
Time Frame: 1-15 minutes after spinal anesthesia.
Monitoring data
Peripheral vascular resistance
Time Frame: 1-15 minutes after spinal anesthesia.
Monitoring data
Secondary Outcomes
- The incidence of hypertension.(1-15 minutes after spinal anesthesia.)
- pH(Immediately after delivery)
- Base excess(Immediately after delivery)
- Partial pressure of oxygen (PO2)(Immediately after delivery)
- APGAR score(5 min after delivery)
- The incidence of post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia.)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia.)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia.)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)