The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.

August 6, 2023 updated by: mohamed abdelghany ali, Cairo University

Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value.

Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

68

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

Yes

Sampling Method

Probability Sample

Study Population

A total of 68 consecutive elderly patients, aged >65 years scheduled for elective infra-umbilical surgical operations under spinal anesthesia will be included in the study.

Description

Inclusion Criteria:

  • 1. 65 years of age or more. 2. ASA score I & II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia.

Exclusion Criteria:

  • Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin

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
The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.
Time Frame: 15 minutes before spinal anesthesia
The incremental changes of measured maximum inferior vena caval diameter after passive leg raising
15 minutes before spinal anesthesia

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ms2022

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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