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This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.
EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.
Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head & neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.
The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.
In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low Bispectral index (BIS) group | BIS range under 40 |
| |
| normal BIS group | BIS range from 40 to 60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS | Device | BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Pediatric Anesthesia Emergence Delirium (PAED) Score | Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, aged between 3 and 5 years, scheduled for strabismus surgery
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| Name | Affiliation | Role |
|---|---|---|
| HYO SEOK NA | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital, department of Anesthesia and pain | Seongnam | Gyenggo-do | 13620 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Bispectral Index (BIS) Group | Bispectral index (BIS) range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
| FG001 | Low Bispectral Index (BIS) Group | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Bispectral Index (BIS) Group | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
| BG001 | Normal BIS Group |
| 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 | the Pediatric Anesthesia Emergence Delirium (PAED) Score | Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes |
|
Adverse event data were collected every 6 months.
In this study, the concentration of inhalational agent was conventional in both group. We didn't manage the concentation intentionally to make BIS lower than 40 even in Low BIS Group. There were no adverse event and/or serious adverse event.
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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 | Low Bispectral Index (BIS) Group | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. YEA JI LEE | Seoul National University Bundang Hospital | +821086307701 | ladydaisy82@naver.com |
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| ID | Term |
|---|---|
| D013285 | Strabismus |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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BIS range from 40 to 60
BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
BIS range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Normal BIS Group | BIS range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. | 0 | 34 | 0 | 34 | 0 | 34 |
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| D003693 |
| Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |