Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children. (PI/AAI)

March 18, 2020 updated by: Hala Saad Abdel-Ghaffar, Assiut University
The aim of this study is to evaluate the validity of perfusion index to determine the level of anesthesia in comparison with auditory evoked potential in children undergoing tonsillectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of the perfusion index as an added monitoring tool during anesthesia provides the anesthetist with a number of benefits. It is a useful tool to forewarn the clinician of possible light planes of anesthesia, allowing for agent dose adjustment. It is a preexisting technology that is already widely available and used in most urban, regional,and rural centers, in both developed and developing countries, is noninvasive, continuous, and inexpensive.

The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method

Study Type

Observational

Enrollment (Actual)

41

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
    • Assiut Governorate
      • Assiut, Assiut Governorate, Egypt, 715715
        • Assiut university main hospital

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

4 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ASA physical status I-II patients aged 4-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study. Excluded from the study will be patients with significant cardiac, renal, pulmonary or hepatic disease.

Description

Inclusion Criteria:

  • Patients aged 3-12 years
  • Elective tonsillectomy due to recurrent or chronic tonsillitis

Exclusion Criteria:

  • Cerebral disease
  • Cardiac disease,
  • Renal disease,
  • Pulmonary disease
  • Hepatic disease.

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
Measure Description
Time Frame
PI
Time Frame: Introperative
Perfusion index detected by pulse oximeter
Introperative
AAI index
Time Frame: Intraoperative
AAI index detected by AEP monitor
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hala S Abdelghaffar, MD, Professor in anesthesia and intensive care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 20, 2018

Primary Completion (ACTUAL)

August 20, 2019

Study Completion (ACTUAL)

August 20, 2019

Study Registration Dates

First Submitted

January 20, 2018

First Submitted That Met QC Criteria

January 20, 2018

First Posted (ACTUAL)

January 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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