UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023190
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email miharaxxxtotoro@yahoo.co.jp

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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.