Anesthesia
Conditions
Brief summary
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
Detailed description
This is a multi-center, prospective, observational, non-invasive, randomized controlled study to collect data to compare the performance of standard practice (SP) group with the BIS™ monitoring (BIS) group. Pediatric patients between the ages of 4 to 18 years undergoing routine sevoflurane general anesthesia with an expected surgical procedure duration of greater than 30 minutes will be recruited. If the surgery is less than 15 minutes, the data will continue to be collected, but will not be included in the data analysis and the subject will be replaced with an additional subject. General surgeries including abdominal, urological, orthopedic, or ophthalmological procedures with an American Society of Anesthesiologists physical status of I - III.
Interventions
The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Masking description
Investigator will be blinded to the BIS value in the Standard Practice Group
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric Subjects (ASA physical status I or II or III) aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
Exclusion criteria
* Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors * Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, hemiplegia, demyelinating disorders, cerebral palsy, congenital anomalies of the brain or spinal cord, or other known neurologic disorders) * Severe developmental delay per assessment of investigator or report of parent/guardian * Airway abnormalities * Pregnancy; subjects of childbearing potential will have a urine screen for pregnancy before surgery * If the process of assessment will interfere with the procedure or the progress of the procedure * Taking psychoactive medications * Taking any medications that may have an impact on the Central Nervous System (CNS) * Planned use of any regional anesthesia; a local field block is not included in this exclusion and can be used at the discretion of the anesthesia provider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-tidal Sevoflurane Concentration | duration of maintenance of anesthesia | Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Each Score on the Wong Baker Faces Scale | up to 4 hours following anesthesia administration | Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most |
| Modified Aldrete Score | up to 4 hours following anesthesia administration | The Modified Aldrete Score assesses the readiness of the subject to be discharged from the post anesthesia care unit (PACU) with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12. |
| Number of Participants With Reported Airway Reflexes | up to 4 hours following anesthesia administration | Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events |
| Clinical Anesthesia Assessment | up to 4 hours following anesthesia administration | recorded as the number of events including movement during procedure, eye opening, hypotension, hypertension, tachycardia, bradycardia, and low oxygen saturation (SpO2) that are common in anesthesia and not considered adverse events |
Countries
United States
Participant flow
Pre-assignment details
Subjects enrolled without randomization to group (n=39) include training subject (29), screen failure (n=4), physician decision (n=2), technical problem (n=1), and other (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Standard Practice Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications. | 76 |
| BIS Group Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress.
BIS Complete Monitoring System: The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BISx™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index. | 56 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disqualified data sets | 10 | 28 |
Baseline characteristics
| Characteristic | Standard Practice | Total | BIS Group |
|---|---|---|---|
| Age, Continuous | 11.2 years STANDARD_DEVIATION 3.8 | 11.1 years STANDARD_DEVIATION 3.9 | 11.0 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 32 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 95 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 34 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) White | 44 Participants | 77 Participants | 33 Participants |
| Region of Enrollment United States | 76 participants | 132 participants | 56 participants |
| Sex: Female, Male Female | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Male | 47 Participants | 73 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 56 |
| other Total, other adverse events | 4 / 76 | 3 / 56 |
| serious Total, serious adverse events | 1 / 76 | 0 / 56 |
Outcome results
Primary
End-tidal Sevoflurane Concentration
Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group.
Time frame: duration of maintenance of anesthesia
Population: Data in table is shown for all ages (total) and broken down by age group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Practice | End-tidal Sevoflurane Concentration | All Ages | 2.1 percent sevoflurane | Standard Deviation 0.5 |
| Standard Practice | End-tidal Sevoflurane Concentration | Age 4-8 years | 2.5 percent sevoflurane | Standard Deviation 0.3 |
| Standard Practice | End-tidal Sevoflurane Concentration | Age 9-12 | 2.2 percent sevoflurane | Standard Deviation 0.6 |
| Standard Practice | End-tidal Sevoflurane Concentration | Age 13-18 | 1.9 percent sevoflurane | Standard Deviation 0.5 |
| BIS Group | End-tidal Sevoflurane Concentration | Age 13-18 | 1.5 percent sevoflurane | Standard Deviation 0.3 |
| BIS Group | End-tidal Sevoflurane Concentration | All Ages | 1.8 percent sevoflurane | Standard Deviation 0.4 |
| BIS Group | End-tidal Sevoflurane Concentration | Age 9-12 | 1.7 percent sevoflurane | Standard Deviation 0.5 |
| BIS Group | End-tidal Sevoflurane Concentration | Age 4-8 years | 2.1 percent sevoflurane | Standard Deviation 0.3 |
Secondary
Clinical Anesthesia Assessment
recorded as the number of events including movement during procedure, eye opening, hypotension, hypertension, tachycardia, bradycardia, and low oxygen saturation (SpO2) that are common in anesthesia and not considered adverse events
Time frame: up to 4 hours following anesthesia administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Practice | Clinical Anesthesia Assessment | Movement during procedure | 5 participants |
| Standard Practice | Clinical Anesthesia Assessment | Bradycardia in recovery | 18 participants |
| Standard Practice | Clinical Anesthesia Assessment | Hypotension during procedure | 1 participants |
| Standard Practice | Clinical Anesthesia Assessment | Hypotention in recovery | 39 participants |
| Standard Practice | Clinical Anesthesia Assessment | Eye opening during procedure | 3 participants |
| Standard Practice | Clinical Anesthesia Assessment | Hypertension in recovery | 24 participants |
| Standard Practice | Clinical Anesthesia Assessment | Hypertension during procedure | 1 participants |
| Standard Practice | Clinical Anesthesia Assessment | Low SPO2 in recovery | 0 participants |
| Standard Practice | Clinical Anesthesia Assessment | Tachycardia in recovery | 31 participants |
| BIS Group | Clinical Anesthesia Assessment | Low SPO2 in recovery | 1 participants |
| BIS Group | Clinical Anesthesia Assessment | Movement during procedure | 5 participants |
| BIS Group | Clinical Anesthesia Assessment | Eye opening during procedure | 3 participants |
| BIS Group | Clinical Anesthesia Assessment | Hypotension during procedure | 0 participants |
| BIS Group | Clinical Anesthesia Assessment | Tachycardia in recovery | 33 participants |
| BIS Group | Clinical Anesthesia Assessment | Bradycardia in recovery | 4 participants |
| BIS Group | Clinical Anesthesia Assessment | Hypotention in recovery | 19 participants |
| BIS Group | Clinical Anesthesia Assessment | Hypertension in recovery | 18 participants |
| BIS Group | Clinical Anesthesia Assessment | Hypertension during procedure | 0 participants |
Secondary
Modified Aldrete Score
The Modified Aldrete Score assesses the readiness of the subject to be discharged from the post anesthesia care unit (PACU) with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12.
Time frame: up to 4 hours following anesthesia administration
Population: Lowest/worst timepoint reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Practice | Modified Aldrete Score | 7.3 score on a scale | Standard Deviation 2.1 |
| BIS Group | Modified Aldrete Score | 8.1 score on a scale | Standard Deviation 2 |
Secondary
Number of Participants With Each Score on the Wong Baker Faces Scale
Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most
Time frame: up to 4 hours following anesthesia administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little More | 19 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt whole lot | 4 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little Bit | 14 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt worst | 4 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt even more | 11 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Not Reported | 5 Participants |
| Standard Practice | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) No Hurt | 19 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Not Reported | 1 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) No Hurt | 5 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little Bit | 18 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little More | 17 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt even more | 4 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt whole lot | 8 Participants |
| BIS Group | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale (Highest score during PACU stay) Hurt worst | 3 Participants |
Secondary
Number of Participants With Reported Airway Reflexes
Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events
Time frame: up to 4 hours following anesthesia administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Practice | Number of Participants With Reported Airway Reflexes | Coughing | 13 participants |
| Standard Practice | Number of Participants With Reported Airway Reflexes | Choking | 0 participants |
| Standard Practice | Number of Participants With Reported Airway Reflexes | Laryngospasm | 0 participants |
| BIS Group | Number of Participants With Reported Airway Reflexes | Coughing | 4 participants |
| BIS Group | Number of Participants With Reported Airway Reflexes | Choking | 0 participants |
| BIS Group | Number of Participants With Reported Airway Reflexes | Laryngospasm | 0 participants |