Adverse Effect
Conditions
Brief summary
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
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.
Interventions
DRUGAlpha-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.
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pH | Immediately after delivery | From umbilical arterial blood gases. |
| Base excess | Immediately after delivery | From umbilical arterial blood gases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Countries
China
Contacts
STUDY_CHAIRYi Chen, M.D.
General Hospital of Ningxia Medical University
Outcome results
None listed