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Ultrasound Guided Fluid Loading Before Spinal Anesthesia

Ultrasound Guided Fluid Loading Before Spinal Anesthesia for Cesarean Section in Hypovolemic Parturient: Double-Blind Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108881
Acronym
EHCOPRESPA
Enrollment
116
Registered
2025-08-07
Start date
2024-05-01
Completion date
2025-03-25
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Spinal Anesthesia, Hypotension, Hypovolemia, Sympathetic Blockade, Fluid Loading

Brief summary

Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections. The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal anesthesia. It was a double-blind, randomized controlled trial study conducted on hypovolemic parturients, scheduled for cesarean section. investigators compared ultrasound guided correction of hypovolemia to a standard care protocol without preloading. Hypovolemia was defined as a ≥12% increase in the variation of the velocity-time integral of subaortic blood flow during a passive leg raising test. Preloading was guided by the variation of the velocity-time integral of subaortic blood flow during volume expansion tests.

Detailed description

In the literature, numerous studies have compared the different pre-filling and co-filling protocols with different solutes. The majority of them conclude that co-filling is superior to pre-filling when the same type of solute is used. Pre-filling with crystalloids was then abandoned in favor of co-filling with crystalloids It is essential to remember that several invasive or non-invasive means of hemodynamic monitoring have previously been validated in pregnant women The use of invasive tools for assessing blood volume, particularly arterial and central venous catheters, is limited given the brevity of obstetric procedures, the risk of morbidity in awake patients and their high costs. Although non-invasive methods are preferable, some remain imperfect, notably carotid Doppler and bioimpedance devices Transthoracic echocardiography stands out as a particularly reliable and relevant non-invasive tool for assessing cardiac output and blood volume in parturients It allows analysis of the variation of the subaortic velocity time integral (∆ ITV s-a) during the passive leg raise test (LET). It is the only dynamic preload parameter validated in patients during spontaneous ventilation, thus allowing assessment of blood volume. After reviewing the literature, the investigators found no studies about, exclusively hypovolemic patients, the effect of combining pre-filling with co-filling with crystalloids, monitored by echocardiographic preload-dependence indices, on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia. In this study, monitoring was performed by transthoracic echocardiography, based on the variation in subaortic TVI following the passive leg raise test and vascular fluid tests. The objective of this prospective randomized study was to evaluate the efficacy of ultrasound-guided correction of hypovolemia by pre-filling with crystalloids on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.

Interventions

DRUGC

isotonic saline solution infusion (fluid preloading) to achieve correction of hypovolemia before spinal anesthesia using cardiac ultrasoud guidance by measurment of VTI variation after a 250ml saline solution loading, with a maximum of 4 challenges, until hypovolemia complete correction

DRUGT

isotonic saline solution coloading after spinal anesthesia associated with recsue boluses of Ephedrine would be the standard of care in this arm. No correction of hypovolemia is done before spinal anesthesia. parturients receive a cristalloid coloading with saline isotonic solution with rescue boluses of ephedrine if hypotesion happens after spinal anesthesia

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

participant was blinded outcome assessors performed ultrasound to assess volemia but later were not aware of randomization care givers did know about randomization in order to give treatement according to the allocation

Intervention model description

hypovolemic participant were chosen among all pauturient scheduled for cesarean section. hypovolemia was detected using VTI variation mesurment in spine position with passive legs raising then they were randomized into two groups group C: had an ultrasound guided preloading with 1 to 4 fluid challenges of 250 ml of cristalloids each group T: received the standard care, ie: critalloids co-loading with recsue ephedrine doses if needed

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

ASA II score, singleton pregnancy cesarean section

Exclusion criteria

Spinal anesthesia failure general anesthesia postpartum hemorhage saline solution volume \> 1000 ml for preloading echocardiography: difficulties Poor echogenicity

Design outcomes

Primary

MeasureTime frameDescription
incidence of post-spinal anesthesia arterial hypotension during surgery60 minutesThe incidence of intraoperative post-spinal hypotension Defined by a drop in blood pressure (BP) of more than 20% of its reference value, or a blood pressure (BP) \< 100 mmHg

Secondary

MeasureTime frameDescription
Duration of hypotensive episode (min)60 minutesthe duration of hypotension from the onset of the first episode until reaching normal ranges again
Depth of hypotension (% fall from baseline value)60 minuteshypotension is Defined by a drop in SBP of more than 20% of its baseline value, or a SBP \< 100mmHg
Variation in intraoperative cardiac output (% drop from baseline)60 minutescardiac output is expected to rise of fall from its baseline and is caculated in percenttages of variation from its baseline
Consumption of per-op vasopressors (mg of ephedrine)60 minutestotal dose of ephedrine given in case of hypotension
Time to onset of the first episode of arterial hypotension (min)60 minuteshypotension is Defined by a drop in SBP of more than 20% of its reference value, or a SBP \< 100mmHg
Incidence of maternal bradycardia (%) -60 minutes(Heart Rate \< 50 bpm)
Incidence of intraoperative nausea and vomiting (%)60 minutessnausea and vomiting usually at the moments of severe hypotension
Fetal pH at the umbilical cord at birth.30 minutesright after delivery
Newborn APGAR score at the first and fifth minute30 minutesat birth
Volume of cristalloids and colloids infused (ml)60 minutestotal volume of critalloids given either when preloading bfeore spinal anesthesia or while coloading after spinal anesthesia

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026