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

NCT03412214 | Completed DMC

• 1 other identifier: 17300155
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Awareness, Anesthesia

Outcome Measures

Primary Outcomes (2)

• PI

  Perfusion index detected by pulse oximeter

  Introperative

• AAI index

  AAI index detected by AEP monitor

  Intraoperative

Interventions

Perfusion index detected by pulse oximeter DEVICE

Perfusion index detected by pulse oximeter

Also known as: 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.

Also known as: AAI index detected by AEP monitor.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33991553 DERIVED

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala S Abdelghaffar, MD

  Professor in anesthesia and intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: January 26, 2018
• Study Start: March 20, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)