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

NCT04886089 | Completed

• 1 other identifier: N-126-2020
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-induction Hypotension

Outcome Measures

Primary Outcomes (1)

• The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension

  before induction of general anesthesia

Interventions

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

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abeer Ahmed Mohamed

Maadi, Cairo Governorate, 11728, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 13, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

EG (1)