UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008087
Receipt number R000009422
Scientific Title Efficacy of endotracheal lidocaine with continuous infusion of remifentanil in attenuating tube-induced coughing during emergence from TIVA
Date of disclosure of the study information 2012/06/02
Last modified on 2012/06/02 17:06:37

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Basic information

Public title

Efficacy of endotracheal lidocaine with continuous infusion of remifentanil in attenuating tube-induced coughing during emergence from TIVA

Acronym

endotracheal lidocaine and continuous infusion of remifentanil for preventing tube-induced coughing

Scientific Title

Efficacy of endotracheal lidocaine with continuous infusion of remifentanil in attenuating tube-induced coughing during emergence from TIVA

Scientific Title:Acronym

endotracheal lidocaine and continuous infusion of remifentanil for preventing tube-induced coughing

Region

Japan


Condition

Condition

tympanoplasty

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

During emergence from anaesthesia, tube induced coughing lead to an increase in heart rate and blood pressure and might have a harmful influence on patient's hemodynamics.
We hypothesized that combining techniques (endotracheal lidocaine, continuous infusion of remifentanil )could attenuate tube-induced coughing.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the number of subjects who experienced coughing during emergence from anaesthesia

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

endotracheal lidocaine

Interventions/Control_2

nothing administered

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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

ASA1-2 patients aged 20-69 years undergoing tympanoplasty by general anaesthesia

Key exclusion criteria

patients who have anticipated difficult tracheal intubation, risk factors for perioperative aspiration of gastric contents or respiratory tract symptom

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Yamasaki

Organization

Osaka City University Graduate School of Medicine

Division name

Anesthesiology

Zip code


Address

1-5-7 Asahi-machi Abeno-ku Osaka-city

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka Rosai Hospital

Division name

Anesthesiology

Zip code


Address


TEL

090-2000-3055

Homepage URL


Email



Sponsor or person

Institute

Osaka Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Rosai Hospital

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

2012 Year 06 Month 02 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

2009 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 03 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



Management information

Registered date

2012 Year 06 Month 02 Day

Last modified on

2012 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009422


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name