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Ultrasound Guided Fluid Loading Before Spinal Anesthesia

NCT07108881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

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

Interventions

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

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

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-12-01
Completion
2025-03-25

Countries

  • Tunisia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108881 on ClinicalTrials.gov