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

Awareness, Anesthesia Clinical Trial

— PI/AAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412214
• Other study ID #: 17300155
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Awareness, Anesthesia
• Intraoperative Awareness

Intervention

Device:
• Perfusion index detected by pulse oximeter
Perfusion index detected by pulse oximeter
• AAI
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.

Locations

Country	Name	City	State
Egypt	Assiut university main hospital	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PI	Perfusion index detected by pulse oximeter	Introperative
Primary	AAI index	AAI index detected by AEP monitor	Intraoperative