UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014026 |
|---|---|
| Receipt number | R000016163 |
| Scientific Title | Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes and sore throat during extubation. |
| Date of disclosure of the study information | 2014/05/22 |
| Last modified on | 2022/02/28 14:53:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes and sore throat during extubation.
Acronym
Examination of the procedures for suppressing adverse effects such as hemodynamic changes and sore throat during extubation.
Scientific Title
Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes and sore throat during extubation.
Scientific Title:Acronym
Examination of the procedures for suppressing adverse effects such as hemodynamic changes and sore throat during extubation.
Region
| Japan |
Condition
Condition
Patients who undergo surgeries under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop methods for prevention of extubation-induced adverse effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood pressure and heart rate before and after extubation.
Key secondary outcomes
The number of coughs before and after extubation and the degree of sore throat assessed by visual analogue scale and hoarseness after extubation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
An endotracheal tube cuff filled with alkalized lidocaine.
Interventions/Control_2
An endotracheal tube cuff filled with saline.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who required a tracheal intubation.
Key exclusion criteria
Patients with anticipated difficult airway, patients who required a vasoactive agents after end of surgery, patients who were pretreated with beta-blockers.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikito Kawamata |
Organization
Shinshu University School of Medicine
Division name
Department of anesthesiology and resuscitrogy
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372670
kawamata@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Ishida |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372670
Homepage URL
kumiko_m@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
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
| 2014 | Year | 05 | Month | 22 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 22 | 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
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016163
