Hemodynamic Instability Clinical Trial
Official title:
Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses During Spinal Anesthesia for Caesarean Section in Patients With Severe Preeclampsia: a Randomized, Controlled Trial
Verified date | January 2024 |
Source | General Hospital of Ningxia Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 21, 2024 |
Est. primary completion date | January 21, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 18-45 years - Primipara or multipara - Singleton pregnancy =32 weeks - American Society of Anesthesiologists physical status classification II to III - Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: - Baseline blood pressure =180 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 |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Ningxia Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac output (CO) | Evaluated by the VIGILCO monitoring system. | 1-30 minutes after spinal anesthesia. | |
Primary | Stroke volume (SV) | Evaluated by the VIGILCO monitoring system. | 1-30 minutes after spinal anesthesia | |
Primary | Systemic vascular resistance (SVR) | Evaluated by the VIGILCO monitoring system. | 1-30 minutes after spinal anesthesia | |
Secondary | Overall stability of systolic blood pressure control versus baseline | Evaluated by performance error (PE) | 1-30 minutes after spinal anesthesia | |
Secondary | Overall stability of heart rate control versus baseline | Evaluated by performance error (PE) | 1-30 minutes after spinal anesthesia | |
Secondary | The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-30 minutes after spinal anesthesia. | |
Secondary | The incidence of severe post-spinal anesthesia hypotension. | Systolic blood pressure (SBP) < 60% of the baseline | 1-30 minutes after spinal anesthesia. | |
Secondary | The incidence of nausea and vomiting. | Presence of nausea and vomiting in patients after spinal anesthesia | 1-30 minutes after spinal anesthesia | |
Secondary | The incidence of bradycardia. | Heart rate < 60 beats/min. | 1-30 minutes after spinal anesthesia | |
Secondary | The incidence of hypertension. | Systolic blood pressure (SBP) >120% of the baseline. | 1-30 minutes after spinal anesthesia | |
Secondary | pH | From umbilical arterial blood gases. | Immediately after delivery | |
Secondary | Partial pressure of oxygen (PO2) | From umbilical arterial blood gases. | Immediately after delivery | |
Secondary | Base excess (BE) | From umbilical arterial blood gases. | Immediately after delivery | |
Secondary | APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 min after delivery | |
Secondary | APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 min after delivery |
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