UMIN-CTR Clinical Trial

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

postoperative abnormal behaviors such as agitation or restless in children undergoing general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

miharaxxxtotoro@yahoo.co.jp

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

Email

miharaxxxtotoro@yaoo.co.jp

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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