N/A
Completed N=50
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Anesthesia · Child
Source: ClinicalTrials.gov NCT02240368 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: BISPECTRAL Index — 0.6; 0.66; 0.73 units on a scale — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BISPECTRAL Index |
0.6; 0.66; 0.73 | <0.01 sig |
| PRIMARY Entropy |
0.64; 0.66; 0.72 | <0.01 sig |
| SECONDARY BISPECTRAL Index Awaking |
75; 86; 81 | 0.01 sig |
| SECONDARY Entropy Awaking |
63; 96; 86 | <0.01 sig |
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
Data sourced from ClinicalTrials.gov (NCT02240368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.