Clinical trial NCT02240368: Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Official title: Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Child
Keywords: Depth anesthesia monitors
Children anesthesia
Bispectral monitor
Entropy monitor
Lead sponsor: University of Foggia
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2014-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: BISPECTRAL Index
timeFrame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
measure: Entropy
timeFrame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
Secondary outcomes:
measure: BISPECTRAL Index Awaking
timeFrame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
measure: Entropy Awaking
timeFrame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: FG
Study officials:
affiliation: University of Foggia
name: Michele Dambrosio, Medic
role: STUDY_CHAIR
affiliation: University of Foggia
name: Gilda Cinnella, Medic
role: STUDY_DIRECTOR
affiliation: University of Foggia
name: Alberto Sciusco, medic
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Foggia
name: Pasquale Raimondo, Medic
role: PRINCIPAL_INVESTIGATOR
References: