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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010053
Receipt No. R000011772
Scientific Title Effect of lidocaine on preventing laryngospasm: systematic review and meta-analysis.
Date of disclosure of the study information 2013/02/18
Last modified on 2014/04/06

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Basic information
Public title Effect of lidocaine on preventing laryngospasm: systematic review and meta-analysis.
Acronym Effect of lidocaine on preventing laryngospasm: systematic review and meta-analysis.
Scientific Title Effect of lidocaine on preventing laryngospasm: systematic review and meta-analysis.
Scientific Title:Acronym Effect of lidocaine on preventing laryngospasm: systematic review and meta-analysis.
Region
Japan

Condition
Condition laryngospasm
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether lidocaine is effective to prevent laryngospasm or not
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome of this present meta-analysis was the incidence of laryngospasm.
Key secondary outcomes

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
15 years-old >=
Gender Male and Female
Key inclusion criteria All randomized controlled trials comparing lidocaine with any comparator (i.e., placebo, any drugs, or no treatment) that reported the incidence of laryngospasm are included in this study. Eligibility is not restricted by language, type of surgery, patient age, or anesthetic technique.
Key exclusion criteria We exclud studies which did not have adequate comparator. We also exclud data from case reports, comments or letters to the editor, reviews, and animal studies.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Mihara
Organization Kanagawa Children's Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL 045-711-2351
Email miharaxxxtotoro@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Mihara
Organization Kanagawa Children's Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan
TEL 045-711-2351
Homepage URL
Email miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute Kanagawa Children's Medical Center
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 18 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 Completed
Date of protocol fixation
2013 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
2013 Year 06 Month 02 Day
Date trial data considered complete
2013 Year 06 Month 02 Day
Date analysis concluded

Other
Other related information A data collection sheet is created and included data on: (i) ASA-Physical Status, (ii) age, (iii) type of surgery, (iv) type of anesthesia, (v) type of airway device, (vi) route of administration of lidocaine, (vii) dose of lidocaine , (viii) timing of administration, (ix) timing of assessing laryngospasm, (x) type of control (i.e., placebo, other drug, or no treatment), (xi) primary outcome of individual studies, patient number of (xii)lidocaine group and (xiii) control group, number of incidence of laryngospasm in (xiv) lidocaine group and (xv) control group. When multiple control groups including placebo group were made in individual studies, we choose the placebo group as a comparator group in this meta-analysis. Two authors (TM and KU) extract the data independently from the studies included and then cross-check the data. We assess the risk of bias as described by the Cochrane Handbook for Systematic Reviews of Interventions. Subgroup analyses are performed for the primary outcome according to the route of administration, the dose of lidocaine, patient age, and risk of bias. Dichotomous data are summarized using risk ratio (RR) with a 95% confidence interval (CI). For statistically significant differences in outcome, the number needed to treat (NNT) is calculated in order to estimate the overall clinical impact of the intervention. Heterogeneity is quantified with the I2 statistic. To combine the results of the studies, we use the random effect model or fixed effect model according to the heterogeneity. Publication bias was assessed using a funnel plot and a Begg's rank correlation test. In the case of suspected publication bias we intended to use the trim and fill method to assess the impact of potential publication bias.

Management information
Registered date
2013 Year 02 Month 16 Day
Last modified on
2014 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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