UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023190 |
|---|---|
| Receipt number | R000026734 |
| Scientific Title | Development of a risk scale for emergence agitation after general anesthesia in children |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2016/07/15 18:06:50 |
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Basic information
Public title
Development of a risk scale for emergence agitation after general anesthesia in children
Acronym
Development of a risk scale for emergence agitation after general anesthesia in children
Scientific Title
Development of a risk scale for emergence agitation after general anesthesia in children
Scientific Title:Acronym
Development of a risk scale for emergence agitation after general anesthesia in children
Region
| Japan |
Condition
Condition
inguinal hernia, adenoid hypertrophy, tonsillar hypertrophy, unilateral strabismus, cryptorchidism, otitis media, and other minor surgeries
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this two-phased study was 1) to determine predictors of EA after general anesthesia in children and develop an EA risk scale using the predictors with their logarithm of odds ratio in retrospective study (development phase), and 2) to confirm validity of the EA risk scale in the prospective cohort study (validation phase).
Basic objectives2
Others
Basic objectives -Others
The goal of this two-phased study was 1) to determine predictors of EA after general anesthesia in children and develop an EA risk scale using the predictors with their logarithm of odds ratio in retrospective study (development phase), and 2) to confirm validity of the EA risk scale in the prospective cohort study (validation phase).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of the EA risk scale and confirmation its validity.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | months-old | < |
Age-upper limit
| 96 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
We enrolled patients with ASA physical status I or II aged from 1.5 to 8 years who were scheduled to undergo general anesthesia. Operative procedures included inguinal hernia repair, adenoidectomy and/or tonsillectomy, unilateral strabismus surgery, cryptorchidism repair, tympanostomy tube insertion, and other minor surgeries.
Key exclusion criteria
We excluded patients who took psychotropic drugs or has mental retardation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maai Hino |
Organization
Itabashi Chuo Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Azusawa 2-12-7, Itabashi-ku, Tokyo, Japan
TEL
03-3967-1181
mhino0@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Kanagawa Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan
TEL
045-711-2351
Homepage URL
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Children's Medical Center, Yokohama, Japan
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神奈川県立こども医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We developed the EA risk scale by using the data from the previous RCT in our hospital. The EA risk scale consisted of four domains; age, PAB score, operative procedure, and anesthesia time. In addition, the EA risk scale showed an excellent predictive performance (c-index > 0.8) in our validation cohort.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 07 | Day |
Other
Other related information
The EA risk score ranged from 1 to 23 points. The area under the ROC curve (i.e., the c-index) of the validation phase was 0.81 (95 % CI: 0.72-0.89). The best cut-off point was 11 (sensitivity = 87 %, and specificity = 61 %). The gray zone of the validation phase ranged from 10 to 13 points in which 38 % of all patients were included
Management information
Registered date
| 2016 | Year | 07 | Month | 15 | Day |
Last modified on
| 2016 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026734
