Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.

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.

Study Overview

• Status: Completed
• Conditions: Child; Anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • FG
    • Foggia, FG, Italy, 70100
      • Ospedali Riuniti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Children age between 1 month to 12 months
Group 2; Children age between 13 months and 36 months
Group 3; Children age between 37 months to 144 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BISPECTRAL Index	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.	BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
Entropy	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.	Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BISPECTRAL Index Awaking	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	reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Entropy Awaking	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	reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

Collaborators and Investigators

• Sponsor: University of Foggia
• Collaborators: University College, London
• Investigators: Study Chair: Michele Dambrosio, Medic, University of Foggia; Principal Investigator: Alberto Sciusco, medic, University of Foggia; Study Director: Gilda Cinnella, Medic, University of Foggia; Principal Investigator: Pasquale Raimondo, Medic, University of Foggia

Publications and helpful links

Helpful Links

• Speciality school of anesthesia of University of Foggia
• University of Foggia

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Depth anesthesia monitors; Children anesthesia; Bispectral monitor; Entropy monitor
• Other Study ID Numbers: A01