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Spinal-Induced Hypotension in Geriatric Patients

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862298
Collaborator
(none)
120
Enrollment
7
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: venous excess ultrasound score

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)

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pre-Anaesthetic Venous Excess Ultrasound -Score and Their Correlations With the Spinal-Induced Hypotension in Geriatric Patients
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. venous excess ultrasound score [immediate preoperative period before the induction of spinal anesthesia]

    score used to assess venous circulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
tarek abdel hay mostafa, principle investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT05862298
Other Study ID Numbers:
  • postspinal hypotension
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypotension

Study Results

No Results Posted as of May 17, 2023