Ultrasound Guided Fluid Loading Before Spinal Anesthesia (EHCOPRESPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension; Spinal Anesthesia; Hypovolemia; Fluid Loading; Sympathetic Blockade
• Intervention / Treatment: Drug: C; Drug: T

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1007
    • Tunis maternity and neonatology center, minisetry of public health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group C; hypovolemic parturient receiving cardiac -ultrasound -VTI guided cristalloid preloading with 1 to 4 fluid challenges of 250 ml each until they reach a normal volemic state before receiving spinal anesthesia	Drug: C; 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
Placebo Comparator: groupT; hypovolemic parturient reiving the standard care ie; they dont receive any preloading but coloading with critalloids with rescue boluses of ephedrine if hypotension happens	Drug: T; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-spinal anesthesia arterial hypotension during surgery	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	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hypotension; Hypovolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Pharmaceutical Solutions; Ephedrine
• Other Study ID Numbers: 0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No