Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240368
• Other study ID #: A01
• Status: Completed
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Child

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Foggia	FG

Sponsors (2)

Lead Sponsor	Collaborator
University of Foggia	University College, London

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   Anesthetic and surgery department of hospital of Foggia
•   Speciality school of anesthesia of University of Foggia
•   University of Foggia