UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009900 |
|---|---|
| Receipt number | R000011595 |
| Scientific Title | Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials. |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2016/08/03 10:26:36 |
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Basic information
Public title
Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials.
Acronym
Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials.
Scientific Title
Effects of droperidol on postoperative abnormal behaviors in children undergoing general anesthesia: Systematic review and meta-analysis of randomized controlled trials.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2918
miharaxxxtotoro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Mihara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL
045-711-2351
Homepage URL
miharaxxxtotoro@yaoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 29 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011595
