Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| low Bispectral index (BIS) group BIS range under 40 |
Device: BIS
BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
|
| normal BIS group BIS range from 40 to 60 |
Device: BIS
BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital, department of Anesthesia and pain | Seongnam | Gyenggo-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Seoul National University Bundang Hospital
Investigators
- Study Director: HYO SEOK NA, Seoul National University Bundang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-1503-289-004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Normal Bispectral Index (BIS) Group | Low Bispectral Index (BIS) Group |
|---|---|---|
| Arm/Group Description | 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. | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. |
| Period Title: Overall Study | ||
| STARTED | 35 | 33 |
| COMPLETED | 34 | 28 |
| NOT COMPLETED | 1 | 5 |
Baseline Characteristics
| Arm/Group Title | Low Bispectral Index (BIS) Group | Normal BIS Group | Total |
|---|---|---|---|
| Arm/Group Description | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. | 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. | Total of all reporting groups |
| Overall Participants | 28 | 34 | 62 |
| Age (Count of Participants) | |||
| <=18 years |
28
100%
|
34
100%
|
62
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
53.6%
|
18
52.9%
|
33
53.2%
|
| Male |
13
46.4%
|
16
47.1%
|
29
46.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
Outcome Measures
| Title | the Pediatric Anesthesia Emergence Delirium (PAED) Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Low Bispectral Index (BIS) Group | Normal BIS Group |
|---|---|---|
| Arm/Group Description | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. | 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. |
| Measure Participants | 28 | 34 |
| T1 (on arrival PACU) |
12.5
(5.0)
|
11.4
(5.4)
|
| T2 (15 minutes after T1) |
6.5
(1.3)
|
5.4
(3.4)
|
| T3 (15 minutes after T2) |
3.2
(2.0)
|
3.4
(2.5)
|
Adverse Events
| Time Frame | Adverse event data were collected every 6 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Low Bispectral Index (BIS) Group | Normal BIS Group | ||
| Arm/Group Description | BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient. | 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. | ||
All Cause Mortality |
||||
| Low Bispectral Index (BIS) Group | Normal BIS Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/34 (0%) | ||
Serious Adverse Events |
||||
| Low Bispectral Index (BIS) Group | Normal BIS Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/34 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Low Bispectral Index (BIS) Group | Normal BIS Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/34 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. YEA JI LEE |
|---|---|
| Organization | Seoul National University Bundang Hospital |
| Phone | +821086307701 |
| ladydaisy82@naver.com |
- B-1503-289-004