Clinical trial NCT05133271: Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean
Spinal Anesthesia
Keywords: Passive leg raise test (PLR)
Cesarean section
Spinal anesthesia
Maternal arterial hypotension
Phenylephrine requirements
Norepinephrine requirements
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal arterial hypotension
timeFrame: Day 0
measure: Positivity of passive leg raise test
timeFrame: Day 0
measure: Positive passive leg raise test performance
timeFrame: Day 0
Secondary outcomes:
measure: Total dose of norepinephrine
timeFrame: Day 0
measure: Onset of severe arterial hypotension
timeFrame: Day 0
measure: Onset of nausea and vomiting
timeFrame: Day 0
measure: Occurrence of disturbances of consciousness
timeFrame: Day 0
measure: Occurrence of sedation and agitation
timeFrame: Day 0
measure: Assessment of fetal well-being
timeFrame: Day 0
measure: Quality of ultrasound images
timeFrame: Day 0
measure: Relative or absolute hypovolemia
timeFrame: Day 0
measure: Right ventricle systolic or diastolic dysfunction
timeFrame: Day 0
measure: Left ventricle systolic and diastolic dysfunction
timeFrame: Day 0
measure: Pericardial effusion
timeFrame: Day 0
measure: Maternal comfort during the passive leg raising
timeFrame: Day 0
measure: Heart rate
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Xavier Repessé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hawa Keita-Meyer, MD, PhD
role: STUDY_DIRECTOR
References: