An observational study in Anesthesia and Child, sponsored by University of Foggia. Completed at 1 site in Italy. Open to participants aged 1 Month to 12 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by University of Foggia · Observational
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.
University of Foggia is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery
Exclusion Criteria:
Children age between 1 month to 12 months
Children age between 13 months and 36 months
Children age between 37 months to 144 months
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.
Time frame: 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.
Time frame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
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
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
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
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
| Milestone | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Started | 9 | 22 | 19 |
| Completed | 8 | 22 | 18 |
| Not completed | 1 | 0 | 1 |
| Withdrew: Surgery lasted less then 20 minutes | 1 | 0 | 0 |
| Withdrew: Entropy failed to detect more than 50% | 0 | 0 | 1 |
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.
| units on a scale | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| BISPECTRAL Index | 0.6 (0.57 to 0.61) | 0.66 (0.64 to 0.67) | 0.73 (0.71 to 0.74) |
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.
| units on a scale | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Entropy | 0.64 (0.62 to 0.65) | 0.66 (0.65 to 0.68) | 0.72 (0.71 to 0.74) |
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
| units on a scale | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| BISPECTRAL Index Awaking | 75 (62 to 78) | 86 (77 to 92) | 81 (74 to 88) |
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
| units on a scale | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Entropy Awaking | 63 (49 to 71) | 96 (93 to 98) | 86 (78 to 96) |
Collected over Whole period of study from January 2014 to November 2014. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/8 (0%) | 0/8 (0%) |
| Group 2 | — | 0/22 (0%) | 0/22 (0%) |
| Group 3 | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| <=18 years | 8 | 22 | 18 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(months) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Mean | 6.63 ± 3.7 | 24.95 ± 8.0 | 82.22 ± 33.8 | 43.38 ± 37.56 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Female | 4 | 8 | 9 | 21 |
| Male | 4 | 14 | 9 | 27 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Italy | 8 | 22 | 18 | 48 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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