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OpenTrials
Completed

NCT Number: NCT04886089

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

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

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abeer Ahmed Mohamed

Maadi, Cairo Governorate, 11728, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pleth variability index for prediction of post-induction hypotension

Device

The use of the baseline Pleth variability index values for prediction of occurrence of post-induction hypotension

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
May 13, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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