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CompletedNCT05862298Updated Feb 4, 2025

Spinal-Induced Hypotension in Geriatric Patients

An observational study in Spinal Induced Hypotension, Geriatric Population and Intravascular Volume, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Tanta University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
65 Years and older
Sex
All
01

Study summary

The study will be conducted to asses preoperative condition of venous system by VExUS score and it's relation with the incidence of spinal induced hypotension in geriatric patients undergoing surgery with spinal anaesthesia.

Read the detailed description

An assessment of the intravascular volume deficit prior to the spinal anaesthesia conduction may help to predict the occurrence of a critical decrease in blood pressure, so several indices have been proposed to assess it's status depending on either a fluid challenge or an assessment of heart-lung interaction. Heart rate variability, passive leg raise test, and peripheral perfusion index have revealed good abilities to predict spinal induced hypotension. The inferior vena cava (IVC) collapsibility index provides high diagnostic accuracy in predicting spinal induced hypotension The VeXUS score is a four-staged validated protocol which evaluates the presence and severity of systemic venous congestion in the inferior vena cava (IVC) and organs (liver, gut, and kidneys) by evaluating the (IVC) diameter, venous waveforms of the hepatic vein (HV), portal vein (PV), and interlobar renal veins using colour Doppler (CD) and pulsed wave Doppler (PWD)

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Conditions studied

  • Spinal Induced Hypotension
  • Geriatric Population
  • Intravascular Volume

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 120 is above the median of 84 across 294 observational studies indexed under Hypotension.

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Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

geriatric patients aged greater 65 years scheduled for Lower body surgeries under spinal anaesthesia with BMI less than 30 kg/m2 with ASA I-III. These populations are high susceptible for development of spinal induced hypotension with high incidence of morbidity and mortality

Inclusion criteria

  • . Patients aging 65 or older
  • Lower body surgeries to be done with spinal anaesthesia
  • BMI less than 30 kg/m2.
  • Patients with ASA I-III

Exclusion criteria

Exclusion Criteria:

  • Patient refusal
  • Major bloody surgeries (class c surgeries)
  • Patients with a history of cardiovascular disorders including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, AF
  • Patients with a history of respiratory disorders
  • Patients with cirrhotic liver
  • Patients with pulmonary hypertension
  • Patients with renal diseases
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testvenous excess ultrasound score

    Venous congestion is classified into 4 grades. If the Inferior vena cava is not plethoric, there is deemed to be no congestion (grade 0), and further Doppler examination is not performed. When the IVC is plethoric but there are no severely abnormal waveforms (defined as S-wave reversal on hepatic, \>50% pulsatility on portal, and a monophasic pattern on intrarenal Doppler), congestion is considered to be mild (grade 1). Plethoric IVC with at least 1 severely abnormal pattern is considered to be moderate congestion (grade 2), while 2 or more abnormal Doppler patterns constitute severe congestion (grade 3)

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What researchers measure

Primary outcomes

  1. venous excess ultrasound score

    score used to assess venous circulation

    Time frame: immediate preoperative period before the induction of spinal anesthesia

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Study locations

1 site
  • tarek Abdelhay Mostafa
    Tanta, El Gharbyia 31111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05862298
Lead sponsor
Tanta University
Responsible party
tarek abdel hay mostafa (principle investigator, Tanta University) — Principal investigator
First posted
May 17, 2023
Start date
May 1, 2023
Primary completion
Dec 30, 2024
Completion
Jan 30, 2025
Last update
Feb 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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