The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients

The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients: A Prospective Observational Study

In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia Induced Hypotension
• Intervention / Treatment: Device: positional perfusion index variation

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 202
      • Cairo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 68 consecutive elderly patients, aged >65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.

Description

Inclusion Criteria:

• 65 years of age or more.
• ASA score I & II.
• Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

• Negative consent.
• pre-existing hypertension
• Diabetes mellitus or autonomic neuropathy.
• Emergency operations.
• Absolute contraindications or failure to perform spinal anesthesia.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients.	The sensitivity of incremental change of a measured perfusion index pre and post spinal anesthesia	30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of spinal anesthesia induced hypotension in elderly	incidence of spinal anesthesia induced hypotension in elderly	30 minutes after spinal anesthesia
• The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.	• The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.	30 minutes after spinal anesthesia
• The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.	• The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.	30 minutes after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: N-122-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No