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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05862298
Other study ID # postspinal hypotension
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT03406481 - The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
Completed NCT03673475 - Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness