Anesthesia, Child
Conditions
Keywords
Depth anesthesia monitors, Children anesthesia, Bispectral monitor, Entropy monitor
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 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.
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 monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.
Interventions
None listed
Sponsors
University College, London
University of Foggia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BISPECTRAL Index | BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours | 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. |
| Entropy | Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BISPECTRAL Index Awaking | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia | 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 |
| Entropy Awaking | reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia | 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 |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Children age between 1 month to 12 months | 8 |
| Group 2 Children age between 13 months and 36 months | 22 |
| Group 3 Children age between 37 months to 144 months | 18 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Entropy failed to detect more than 50% | 0 | 0 | 1 |
| Overall Study | Surgery lasted less then 20 minutes | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2 | Group 3 | Group 1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 18 Participants | 8 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 24.95 months STANDARD_DEVIATION 8 | 82.22 months STANDARD_DEVIATION 33.8 | 6.63 months STANDARD_DEVIATION 3.7 | 43.38 months STANDARD_DEVIATION 37.56 |
| Region of Enrollment Italy | 22 participants | 18 participants | 8 participants | 48 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 4 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 22 | 0 / 18 |
| serious Total, serious adverse events | 0 / 8 | 0 / 22 | 0 / 18 |
Outcome results
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.
Time frame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | BISPECTRAL Index | 0.6 units on a scale |
| Group 2 | BISPECTRAL Index | 0.66 units on a scale |
| Group 3 | BISPECTRAL Index | 0.73 units on a scale |
p-value: <0.01bootstrap
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.
Time frame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Entropy | 0.64 units on a scale |
| Group 2 | Entropy | 0.66 units on a scale |
| Group 3 | Entropy | 0.72 units on a scale |
p-value: <0.01bootstrap
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
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | BISPECTRAL Index Awaking | 75 units on a scale |
| Group 2 | BISPECTRAL Index Awaking | 86 units on a scale |
| Group 3 | BISPECTRAL Index Awaking | 81 units on a scale |
p-value: 0.01Wilcoxon (Mann-Whitney)
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
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Entropy Awaking | 63 units on a scale |
| Group 2 | Entropy Awaking | 96 units on a scale |
| Group 3 | Entropy Awaking | 86 units on a scale |
p-value: <0.01Wilcoxon (Mann-Whitney)