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The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-normal BIS ("Lighter" anesthesia) | Experimental | Depth of anesthesia is titrated to a BIS of 55-60 |
|
| Low-normal BIS ("Deeper" anesthesia) | Experimental | Depth of anesthesia is maintained at a BIS level of 40-45 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depth of anesthesia | Other | The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl). |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation. | Within 30 minutes of arrival in recovery room |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Emergence From Anesthesia | The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation. | After the completion of surgery |
| Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Frederick, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center - Eye Center | Durham | North Carolina | 27710 | United States |
Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.
Parents or guardians of children undergoing ophthalmologic surgery were approached, when possible, at their pre-anesthesia evaluation visit. All eligible patients were notified about the study through fliers at their pre-operative visit, and eligible patients who were missed pre-operatively were approached for consent on the day of surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-normal BIS | Depth of anesthesia is titrated to a BIS level of 55-60 |
| FG001 | Low-normal BIS | Depth of anesthesia is titrated to a BIS level of 40-45 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-normal BIS | Depth of anesthesia is titrated to a BIS level of 55-60 |
| BG001 | Low-normal BIS | Depth of anesthesia is titrated to a BIS level of 40-45 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation. | All patients in each group were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Within 30 minutes of arrival in recovery room |
|
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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 | High-normal BIS | Depth of anesthesia is titrated to a BIS level of 55-60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Frederick | Duke University Medical Center | 919-812-6204 | heather.frederick@duke.edu |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.
| Within 30 minutes of arrival in recovery room |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Low-normal BIS |
Depth of anesthesia is titrated to a BIS level of 40-45 |
|
|
|
| Secondary | Time to Emergence From Anesthesia | The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation. | All patients were analyzed | Posted | Mean | Standard Deviation | minutes | After the completion of surgery |
|
|
|
| Secondary | Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) | Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study. | All patients were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Within 30 minutes of arrival in recovery room |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Low-normal BIS | Depth of anesthesia is titrated to a BIS level of 40-45 | 0 | 18 | 0 | 18 |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |