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Completed

NCT Number: NCT05862298

Spinal-Induced Hypotension in Geriatric Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

tarek Abdelhay Mostafa

Tanta, El Gharbyia, 31111, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

venous excess ultrasound score

Diagnostic Test

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)

Primary outcomes

  1. venous excess ultrasound score

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

    score used to assess venous circulation

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Pre-Anaesthetic Venous Excess Ultrasound -Score and Their Correlations With the Spinal-Induced Hypotension in Geriatric Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 17, 2023
Registry last updated
Feb 4, 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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