Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients

April 6, 2025 updated by: Abeer Ahmed, MD, Cairo University

Pre-anesthesia Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients Undergoing General Anesthesia: A Prospective Cohort Study

Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

85

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

  • Egypt
    • Cairo
      • Maadi, Cairo, Egypt, 11728
        • Abeer Ahmed Mohamed

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

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

all patients. Patients ≥ 65 years, ASA physical status I or II, and scheduled for elective surgery under general anesthesia will be enrolled in the study.

Description

Inclusion Criteria:

  • patients with ASA physical status I or II
  • patients will receive general anesthesia

Exclusion Criteria:

  • Patients with a history of cardiorespiratory disorders
  • patients with uncontrolled hypertension or cardiac dysrhythmias
  • Patients with renal or hepatic diseases.
  • Patients with long-standing diabetes and peripheral vascular 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
Time Frame
The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension
Time Frame: before induction of general anesthesia
before induction of general 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 (Actual)

August 1, 2021

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-126-2020

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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