Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.

Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.

Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.

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Detailed Description

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All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.

Conditions

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Anesthesia Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Children age between 1 month to 12 months

No interventions assigned to this group

Group 2

Children age between 13 months and 36 months

No interventions assigned to this group

Group 3

Children age between 37 months to 144 months

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* physical status classification (ASA) I - II
* general balanced anesthesia
* mechanically ventilated with laryngeal mask

Exclusion Criteria

* severe developmental delay
* neurological disorders or receiving treatment with antiepileptic or stimulant
* patients with preexisting lung or cardiac disease
* airway abnormalities
* marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.
* patients receiving local anaesthesia, regional block combined with general anaesthesia
* sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No