Emergence Agitation
Conditions
Keywords
Emergence delirium, Bispectral Index, Depth of anesthesia
Brief summary
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.
Interventions
OTHERDepth of anesthesia
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).
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery * American Society of Anesthesiology (ASA) physical status 1 or 2
Exclusion criteria
* Surgery precluding placement of BIS monitor * Non-English speaking, until additional language consent forms are approved * Previous history of severe emergence agitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | Within 30 minutes of arrival in recovery room | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Emergence From Anesthesia | After the completion of surgery | The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation. |
| Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) | Within 30 minutes of arrival in recovery room | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.
Participants by arm
| Arm | Count |
|---|---|
| High-normal BIS Depth of anesthesia is titrated to a BIS level of 55-60 | 22 |
| Low-normal BIS Depth of anesthesia is titrated to a BIS level of 40-45 | 18 |
| Total | 40 |
Baseline characteristics
| Characteristic | Low-normal BIS | High-normal BIS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 22 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 4.3 years STANDARD_DEVIATION 1.4 | 5.1 years STANDARD_DEVIATION 2.3 | 4.7 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment United States | 18 participants | 22 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 |
Outcome results
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.
Time frame: Within 30 minutes of arrival in recovery room
Population: All patients in each group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-normal BIS | Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | 8.6 units on a scale | Standard Deviation 5.3 |
| Low-normal BIS | Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | 6.7 units on a scale | Standard Deviation 4.6 |
Comparison: Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.p-value: >0.05t-test, 2 sided
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.
Time frame: Within 30 minutes of arrival in recovery room
Population: All patients were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-normal BIS | Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) | 5.3 units on a scale | Standard Deviation 3.3 |
| Low-normal BIS | Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) | 3.5 units on a scale | Standard Deviation 3.8 |
Secondary
Time to Emergence From Anesthesia
The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.
Time frame: After the completion of surgery
Population: All patients were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-normal BIS | Time to Emergence From Anesthesia | 14 minutes | Standard Deviation 5 |
| Low-normal BIS | Time to Emergence From Anesthesia | 12 minutes | Standard Deviation 4 |