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Completed

NCT Number: NCT03412214

Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.

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.

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Key information

Conditions

Awareness, Anesthesia Intraoperative Awareness Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university main hospital

Asyut, Assiut Governorate, 715715, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Perfusion index detected by pulse oximeter

Device

Perfusion index detected by pulse oximeter

Other names: PI

AAI

Device

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.

Other names: AAI index detected by AEP monitor.

Primary outcomes

  1. PI

    Time frame: Introperative

    Perfusion index detected by pulse oximeter

  2. AAI index

    Time frame: Intraoperative

    AAI index detected by AEP monitor

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: PI/AAI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Mar 20, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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