Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

University of Foggia

Status

Completed

Conditions

Child

Anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT02240368

A01

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

1 month to 12 years old

Volunteers

No Healthy Volunteers

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