UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040775 |
|---|---|
| Receipt number | 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 | 2021/06/16 16:52:57 |
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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
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
w205659g@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
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
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046543
