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

Post-induction Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04886089
• Other study ID #: N-126-2020
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: February 2022

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: February 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Post-induction Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension		before induction of general anesthesia