Spinal-Induced Hypotension in Geriatric Patients

Intravascular Volume Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862298
• Other study ID #: postspinal hypotension
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: tarek Mostafa, MD
• Phone: +20403288260
• Email: dr.tarek311[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intravascular Volume
• Spinal Induced Hypotension

Intervention

Diagnostic Test:
• venous 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)

Locations

Country	Name	City	State
Egypt	tarek Abdelhay Mostafa	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	venous excess ultrasound score	score used to assess venous circulation	immediate preoperative period before the induction of spinal anesthesia