An observational study in Awareness, Anesthesia, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by Assiut University · Observational
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.
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
55 studies on the registry are indexed under Intraoperative Awareness; 8 are open to participants now.
This study's enrollment of 41 is below the median of 120 across 28 observational studies indexed under Intraoperative Awareness.
Browse Intraoperative Awareness studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
Perfusion index detected by pulse oximeter
Also known as: PI
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.
Also known as: AAI index detected by AEP monitor.
PI
Perfusion index detected by pulse oximeter
Time frame: Introperative
AAI index
AAI index detected by AEP monitor
Time frame: Intraoperative
Plan to share: No
Ran from Mar 2018 to primary completion in Aug 2019, 17 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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