Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
BISPECTRAL Index	BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours	The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
Entropy	Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours	The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

Secondary Outcome Measures

Name	Time	Method
BISPECTRAL Index Awaking	reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia	In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer
Entropy Awaking	reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia	In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer