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
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
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
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
