UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a risk scale for emergence agitation after general anesthesia in children
Title of the study (Brief title)	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

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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
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Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Maai Hino
Organization	Itabashi Chuo Medical Center
Division name	Department of Anesthesiology
Address	Azusawa 2-12-7, Itabashi-ku, Tokyo, Japan
TEL	03-3967-1181
Email	mhino0@yahoo.co.jp

Public contact
Name of contact person	Takahiro Mihara
Organization	Kanagawa Children's Medical Center
Division name	Department of Anesthesiology
Address	Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan
TEL	045-711-2351
Homepage URL
Email	miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute	Kanagawa Children's Medical Center, Yokohama, Japan Department of Anesthesiology
Institute
Department

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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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026734