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Completed

NCT Number: NCT07108881

Ultrasound Guided Fluid Loading Before Spinal Anesthesia

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.

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Key information

Conditions

Cesarean Section Complications Cardiovascular Diseases Fluid Loading Hypotension Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Anesthesia Sympathetic Blockade Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C

Drug

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

Other names: isotonic saline solution preloading

T

Drug

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

Other names: isotonic saline solution coloading with ephedrine boluses

Primary outcomes

  1. incidence of post-spinal anesthesia arterial hypotension during surgery

    Time frame: 60 minutes

    The 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 outcomes

  1. Time to onset of the first episode of arterial hypotension (min)

    Time frame: 60 minutes

    hypotension is Defined by a drop in SBP of more than 20% of its reference value, or a SBP < 100mmHg

  2. Duration of hypotensive episode (min)

    Time frame: 60 minutes

    the duration of hypotension from the onset of the first episode until reaching normal ranges again

  3. Depth of hypotension (% fall from baseline value)

    Time frame: 60 minutes

    hypotension is Defined by a drop in SBP of more than 20% of its baseline value, or a SBP < 100mmHg

  4. Variation in intraoperative cardiac output (% drop from baseline)

    Time frame: 60 minutes

    cardiac output is expected to rise of fall from its baseline and is caculated in percenttages of variation from its baseline

  5. Consumption of per-op vasopressors (mg of ephedrine)

    Time frame: 60 minutes

    total dose of ephedrine given in case of hypotension

  6. Volume of cristalloids and colloids infused (ml)

    Time frame: 60 minutes

    total volume of critalloids given either when preloading bfeore spinal anesthesia or while coloading after spinal anesthesia

  7. Incidence of maternal bradycardia (%) -

    Time frame: 60 minutes

    (Heart Rate < 50 bpm)

  8. Incidence of intraoperative nausea and vomiting (%)

    Time frame: 60 minutess

    nausea and vomiting usually at the moments of severe hypotension

  9. Fetal pH at the umbilical cord at birth.

    Time frame: 30 minutes

    right after delivery

  10. Newborn APGAR score at the first and fifth minute

    Time frame: 30 minutes

    at birth

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Acronym: EHCOPRESPA

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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