Strabismus
Conditions
Keywords
anesthetic depth, emergence agitation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBIS
BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
Sponsors
Seoul National University Bundang Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* aged between 3 and 5 years * American Society of Anesthesiologists physical status I or II
Exclusion criteria
* American Society of Anesthesiologists physical status over III, * any disease that could affect mental status * pre-existing forehead wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Pediatric Anesthesia Emergence Delirium (PAED) Score | 30 minutes | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 34 |
| Total | 62 |
Baseline characteristics
| Characteristic | Low Bispectral Index (BIS) Group | Normal BIS Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 34 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 34 |
| other Total, other adverse events | 0 / 28 | 0 / 34 |
| serious Total, serious adverse events | 0 / 28 | 0 / 34 |
Outcome results
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.
Time frame: 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Bispectral Index (BIS) Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T1 (on arrival PACU) | 12.5 score on a scale | Standard Deviation 5 |
| Low Bispectral Index (BIS) Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T2 (15 minutes after T1) | 6.5 score on a scale | Standard Deviation 1.3 |
| Low Bispectral Index (BIS) Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T3 (15 minutes after T2) | 3.2 score on a scale | Standard Deviation 2 |
| Normal BIS Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T1 (on arrival PACU) | 11.4 score on a scale | Standard Deviation 5.4 |
| Normal BIS Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T2 (15 minutes after T1) | 5.4 score on a scale | Standard Deviation 3.4 |
| Normal BIS Group | the Pediatric Anesthesia Emergence Delirium (PAED) Score | T3 (15 minutes after T2) | 3.4 score on a scale | Standard Deviation 2.5 |