Clincosm LogoSign in Get a demo

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.

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991063
Collaborator
(none)
68
Enrollment
5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    68 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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.
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients. [15 minutes before spinal anesthesia]

      The incremental changes of measured maximum inferior vena caval diameter after passive leg raising

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohamed abdelghany ali, Lecturer of anesthesia, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05991063
    Other Study ID Numbers:
    • Ms2022
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 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 Aug 14, 2023