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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02240368
Other study ID # A01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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