- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05862298
Spinal-Induced Hypotension in Geriatric Patients
February 3, 2025 updated by: tarek abdel hay mostafa, Tanta University
Pre-Anaesthetic Venous Excess Ultrasound -Score and Their Correlations With the 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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El Gharbyia
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Tanta, El Gharbyia, Egypt, 31111
- tarek Abdelhay Mostafa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
venous excess ultrasound score
Time Frame: immediate preoperative period before the induction of spinal anesthesia
|
score used to assess venous circulation
|
immediate preoperative period before the induction of spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
January 30, 2025
Study Registration Dates
First Submitted
May 8, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- postspinal hypotension
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.