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| Name | Class |
|---|---|
| University College, London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery
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| Name | Affiliation | Role |
|---|---|---|
| Michele Dambrosio, Medic | University of Foggia | Study Chair |
| Gilda Cinnella, Medic | University of Foggia | Study Director |
| Alberto Sciusco, medic | University of Foggia | Principal Investigator |
| Pasquale Raimondo, Medic | University of Foggia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti | Foggia | FG | 70100 | Italy |
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| Label | URL |
|---|---|
| Speciality school of anesthesia of University of Foggia | View source |
| University of Foggia | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Children age between 1 month to 12 months |
| FG001 | Group 2 | Children age between 13 months and 36 months |
| FG002 | Group 3 | Children age between 37 months to 144 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Children age between 1 month to 12 months |
| BG001 | Group 2 | Children age between 13 months and 36 months |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | units on a scale | BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours |
|
Whole period of study from January 2014 to November 2014
No adverse events were expected. No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Children age between 1 month to 12 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Sciusco | University of Foggia | alberto.sciusco@gmail.com |
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| 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 |
| BG002 |
| Group 3 |
Children age between 37 months to 144 months |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Group 2 |
Children age between 13 months and 36 months |
| OG002 | Group 3 | Children age between 37 months to 144 months |
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|
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| 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. | Posted | Number | 95% Confidence Interval | units on a scale | Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours |
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|
|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia |
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|
|
|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia |
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|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Group 2 | Children age between 13 months and 36 months | 0 | 22 | 0 | 22 |
| EG002 | Group 3 | Children age between 37 months to 144 months | 0 | 18 | 0 | 18 |
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