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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040775
Receipt No. R000046543
Scientific Title Effectiveness of acupuncture therapy for the prevention of emergence agitation in children: A meta-analysis with trial sequential analysis
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/15

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Basic information
Public title Effectiveness of acupuncture therapy for the prevention of emergence agitation in children: A meta-analysis with trial sequential analysis
Acronym Effectiveness of acupuncture therapy for the prevention of emergence agitation in children: A meta-analysis with trial sequential analysis
Scientific Title Effectiveness of acupuncture therapy for the prevention of emergence agitation in children: A meta-analysis with trial sequential analysis
Scientific Title:Acronym Effectiveness of acupuncture therapy for the prevention of emergence agitation in children: A meta-analysis with trial sequential analysis
Region
Japan

Condition
Condition Emergence agitation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primarily purpose of this meta-analysis is to assess the incidence of emergence agitation evaluated using a specific assessment tool compared with no treatment, placebo/sham, or standard care in children.
Basic objectives2 Others
Basic objectives -Others N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is the incidence of emergence agitation evaluated using a specific assessment tool. We followed the definitions of the incidence of emergency agitation to the criteria established in each study. When emergence agitation was classified according to severity or points, we extract the data from the severe category. When emergence agitation was evaluated at several time points, we extract the data evaluated immediately after emergence (e.g. data evaluated on the PACU or in the recovery room) in order to extract the data that represented acute emergence agitation.
Key secondary outcomes The secondary outcomes are the absolute value of the emergence agitation score evaluated using a specific assessment tool score, and the pain score evaluated using a specific assessment tool score. Incidence of adverse events such as nausea and vomiting, delayed awakening (Time to extubation, PACU stay duration) are also analyzed.

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Children undergoing general anesthesia and being expected to be extubated in the operating room.
Key exclusion criteria Non-children (aged more than 18).
Children undergoing cardiac surgery with cardiopulmonary bypass or not expected to be extubated at the end of surgery.
Target sample size 0

Research contact person
Name of lead principal investigator
1st name DAISUKE
Middle name
Last name NAKAJIMA
Organization Yokohama City University Graduate School of Data Science
Division name Department of Health Data Science
Zip code 236-0027
Address 22-2 Seto Kanazawa-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL 045-787-2311
Email w205659g@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name DAISUKE
Middle name
Last name NAKAJIMA
Organization Yokohama City University Graduate School of Data Science
Division name Department of Health Data Science
Zip code 236-0027
Address 22-2 Seto Kanazawa-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL 045-787-2311
Homepage URL
Email w205659g@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University Graduate School of Data Science
Address 22-2 Seto Kanazawa-ku, Yokohama-shi, Kanagawa-ken, Japan
Tel 045-787-2311
Email w205659g@yokohama-cu.ac.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study protocol is attached in this pre-registration or can be seen at

http://www-user.yokohama-cu.ac.jp/~masuika/protocol/

<Searches>
We will search the following electronic bibliographic database: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science. We will also search for trial registration sites such as ClinicalTrials.gov and University Medical Information Network Clinical Trial Registry.
<Types of study to be included>
We will include randomized controlled trials (RCTs) that evaluated the effect of acupuncture therapy for the prevention of emergence agitation compared with a placebo, no medication, standard care in children undergoing general anesthesia.
<Risk of bias assessment>
We assess the risk of bias using RoB2 tool for randomized, controlled trials. Trials with 1 or more risk of bias classified as some concerns or high are trials with a high risk of bias. We grade the quality of evidence of the main outcomes using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach with GRADEpro software.
<Strategy for data synthesis and analysis>
We will compare the incidence of the emergence agitation with risk ratio. We will summarize the risk ration with 95% confidence interval. We will use a random effect model to combine the result. Heterogeneity is quantified with I2 statistic. We plan to conduct subgroup analyses according to the following predefined factors when the I2 statistic exceeded 50%: (1) method of acupuncture therapy, (2) selection of points (unilateral or bilateral) (3) type of surgery. Sensitivity analysis is performed for primary outcomes according to the risk of bias (low vs high or unclear). For the primary outcome, Trial Sequential Analysis (TSA) is performed to correct for random error and repetitive testing of accumulating and sparse data.

Management information
Registered date
2020 Year 06 Month 15 Day
Last modified on
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046543

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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