Ultrasound Guided Fluid Loading Before Spinal Anesthesia

NCT07108881 | Completed Phase 4

• 1 other identifier: 0123
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  60 minutes

• Duration of hypotensive episode (min)

  60 minutes

• Depth of hypotension (% fall from baseline value)

  60 minutes

• Variation in intraoperative cardiac output (% drop from baseline)

  60 minutes

• Consumption of per-op vasopressors (mg of ephedrine)

  60 minutes

Study Arms (2)

group C

ACTIVE COMPARATOR

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

groupT

PLACEBO COMPARATOR

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

Interventions

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

Also known as: isotonic saline solution preloading

group C

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

Also known as: isotonic saline solution coloading with ephedrine boluses

groupT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant females sheduled for cesarean delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II score, singleton pregnancy cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Hypotension; Hypovolemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal inverstigator

Model Details: 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

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 7, 2025
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 25, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)