UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046543