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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008087
Receipt No. 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

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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
Institute Osaka Rosai Hospital
Institute
Department

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
URL(English) https://upload.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


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