Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Positivity of passive leg raise test
Study Overview
Brief Summary
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Detailed Description
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia.
Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.
The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test.
Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
- •Written informed consent
Exclusion Criteria
- •No health insurance
- •Urgent cesarean
- •Failure of spinal anesthesia
- •Free and informed consent impossible to obtain (especially due to a language barrier)
- •Severe cardiovascular or neurovascular comorbidities
- •Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...)
- •Background of preeclampsia or eclampsia
- •Severe fetal pathology
Arms & Interventions
Scheduled cesarean section
Patient with scheduled cesarean section under spinal anesthesia.
Intervention: Clinical hemodynamic and echocardiographic evaluation (Other)
Outcomes
Primary Outcomes
Positivity of passive leg raise test
Time Frame: Day 0
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Maternal arterial hypotension
Time Frame: Day 0
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)\> 20% of baseline.
Positive passive leg raise test performance
Time Frame: Day 0
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity \> 90%.
Secondary Outcomes
- Assessment of fetal well-being(Day 0)
- Relative or absolute hypovolemia(Day 0)
- Right ventricle systolic or diastolic dysfunction(Day 0)
- Onset of nausea and vomiting(Day 0)
- Occurrence of disturbances of consciousness(Day 0)
- Quality of ultrasound images(Day 0)
- Total dose of norepinephrine(Day 0)
- Onset of severe arterial hypotension(Day 0)
- Pericardial effusion(Day 0)
- Maternal comfort during the passive leg raising(Day 0)
- Heart rate(Day 0)
- Occurrence of sedation and agitation(Day 0)
- Left ventricle systolic and diastolic dysfunction(Day 0)