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

NCT ID: NCT03412214

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2019-08-20

Brief 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.

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

Conditions

Awareness, Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Perfusion index detected by pulse oximeter

Perfusion index detected by pulse oximeter

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

PI; AAI index detected by AEP monitor.

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor in anesthesia and intensive care

Locations

Assiut university main hospital

Asyut, Assiut Governorate, Egypt

Countries

Egypt

References

Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. Using the Perfusion Index to predict changes in the depth of anesthesia in children compared with the A-line Autoregression Index: an observational study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744169. doi: 10.1016/j.bjane.2021.04.030. Epub 2021 May 12.

Reference Type: DERIVED

PMID: 33991553 (View on PubMed)

Other Identifiers

17300155

Identifier Type: -

Identifier Source: org_study_id