UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials.
Title of the study (Brief title)	Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials.
Region	Japan

Condition
Condition	postoperative abnormal behaviors such as agitation or restless in children undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of droperidol on postoperative abnormal behaviors such as agitation or restless in children undergoing general anesthesia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes of this present meta-analysis are the incidence of postoperative abnormal behaviors such as agitation, restless, or extrapyramidal symptoms.
Key secondary outcomes	The secondary outcomes are the incidence of sedation.

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	All randomized controlled trials comparing droperidol with any comparator (i.e., placebo, any drugs, or no treatment) administered during or before general anesthesia in children are included in this study. Eligibility is not restricted by language, type of surgery, or anesthetic technique.
Key exclusion criteria	We exclude studies which did not report our primary or secondary outcomes (i.e., postoperative abnormal behaviors such as agitation or restless, extrapyramidal symptoms, or sedation). We exclude studies which did not compare droperidol with any comparator (e.g., droperidol and midazolam vs. fentanyl), whereas we include studies "droperidol and drug A vs. drug A" because we can count the study as "droperidol vs. placebo". We also exclude data from abstracts, posters, case reports, comments or letters to the editor, reviews, and animal studies.
Target sample size	0

Research contact person
Name of lead principal investigator	Takahiro Mihara
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2918
Email	miharaxxxtotoro@yahoo.co.jp

Public contact
Name of contact person	Takahiro Mihara
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
Address	2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL	045-711-2351
Homepage URL
Email	miharaxxxtotoro@yaoo.co.jp

Sponsor
Institute	Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 29 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Design and search strategy We search MEDLINE, CENTRAL, Embase, Web of Science, and ClinicalTrials.gov. up to February 1, 2013. In addition, the reference lists of the retrieved full articles are searched. Two authors independently scan the titles and abstracts of reports. If eligibility can not be determined from the title or abstract, the full paper is retrieved. Potentially relevant studies, chosen by at least one author, are retrieved and evaluated in full-text versions. The articles that met the inclusion criteria are assessed separately by two authors, and any discrepancies are resolved through discussion. Data abstraction A data collection sheet is created and include data on: (i) ASA-Physical Status, (ii) age, (iii) type of surgery, (iv) type of anesthesia, (v) route of administration of droperidol, (vi) timing of administration, (vii) dose of droperidol, (viii) type of control, (ix) number of incidence of PONV, number of incidence of postoperative abnormal behaviors such as (x) emergence agitation, (xi) other abnormal behaviors (e.g., restless), (xii) number of incidence of extrapyramidal symptoms, (xiii) number of incidence of sedation or (xiv) sedation time if reported, and (xv) primary outcome of the study. When abnormal behaviors were classified according to severity, we abstract the data of the number of incidence of abnormal behaviors from the most severe category. When multiple control groups including placebo group were made in individual studies, we choice the placebo group as a comparator group in this meta-analysis. Two authors extract the data independently from the studies included and then cross-check the data. Risk of bias assessment We assess the risk of bias as described by the Cochrane Handbook for Systematic Reviews of Interventions.

Management information
Registered date	2013 Year 01 Month 30 Day
Last modified on	2016 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011595