Status:
COMPLETED
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Lead Sponsor:
University of Foggia
Collaborating Sponsors:
University College, London
Conditions:
Anesthesia
Child
Eligibility:
All Genders
1-12 years
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...
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 mo...
Eligibility Criteria
Inclusion
- physical status classification (ASA) I - II
- general balanced anesthesia
- mechanically ventilated with laryngeal mask
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02240368
Start Date
September 1 2014
End Date
December 1 2014
Last Update
August 14 2018
Active Locations (1)
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1
Ospedali Riuniti
Foggia, FG, Italy, 70100