Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly

February 3, 2022 updated by: Bassant M. Abdelhamid, Cairo University

Pre-anesthetic Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly: a Prospective Observational Study.

Spinal anesthesia induces sympathetic blockade and venodilation, thus reducing venous return and the cardiac output. Therefore, assessment of intravascular volume deficit before anesthesia might predict a critical decrease in blood pressure after anesthesia.

Recently, ultrasonographic evaluation of the internal jugular vein (IJV) has been used to reflect intravascular volume status and fluid and as a predictor of hypotension after induction of general anesthesia.

Carotid intima-media thickness (CIMT) has been used to predict atherosclerosis-related events, such as stroke, myocardial infarction, peripheral artery disease, and hypotension after induction of anesthesia with a cut-off value of 0.65 mm of CIMT as a threshold level.

Study Overview

Detailed Description

This study aims to evaluate the ability of preoperative Ultrasonographic assessment of the internal jugular vein (IJV) and Carotid intima-media thickness (CIMT) to predict spinal anesthesia induced hypotension (SAIH).

Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.

Study Type

Observational

Enrollment (Actual)

71

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

      • Cairo, Egypt
        • Kasr Alainy Hospital

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

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.

Description

Inclusion Criteria:

  • Adult patients (>60 years)
  • ASA I-II-III
  • Patients scheduled for elective surgeries under spinal anesthesia.

Exclusion Criteria:

  • Operations which will last for less than 15 minutes.
  • Deep vein thrombosis in the upper extremities.
  • History of radiotherapy or neck surgery.
  • Previous sonographic data show tricuspid or mitral regurgitation or a very distended right atrium and ventricle.
  • Patients with history of valvular or carotid artery surgery, arrhythmia, heart failure.
  • Being unable to lie in a supine position for the necessary measurements.
  • Technical limitations to imaging of the IJV and carotid artery.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.
Time Frame: 10 minutes
(Area under receiver operating characteristic curves)
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.
Time Frame: 10 minutes
(Area under receiver operating characteristic curves)
10 minutes
Incidence of Spinal anesthesia induced hypotension
Time Frame: 20 minutes
Change in mean arterial blood pressure 25% less than the preoperative baseline level.
20 minutes
Carotid intima media thickness.
Time Frame: 10 minutes
IMT is measured as the distance between lumen-intima and media-adventitia interfaces
10 minutes
Norepinephrine consumption
Time Frame: 20 minutes
the total dose of norepiniphrine and number of boluses
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bassant abdelhamid, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

October 7, 2021

Primary Completion (Actual)

November 10, 2021

Study Completion (Actual)

January 21, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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