UMIN-CTR Clinical Trial

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

laryngospasm

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The primary outcome of this present meta-analysis was the incidence of laryngospasm.

Key secondary outcomes

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

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

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

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

Institute

Kanagawa Children's Medical Center

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

18

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

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 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.

Registered date

2013

Year

02

Month

16

Day

Last modified on

2014

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011772