UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004546 |
|---|---|
| Receipt number | R000005431 |
| Scientific Title | Comparative study of remifentanil-propofol with dexmedetomidine versus without dexmedetomidine for tracheobronchial stent insertion |
| Date of disclosure of the study information | 2010/11/12 |
| Last modified on | 2013/01/19 21:54:41 |
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Basic information
Public title
Comparative study of remifentanil-propofol with dexmedetomidine versus without dexmedetomidine for tracheobronchial stent insertion
Acronym
Comparative study of remifentanil-propofol with dexmedetomidine versus without dexmedetomidine for tracheobronchial stent insertion
Scientific Title
Comparative study of remifentanil-propofol with dexmedetomidine versus without dexmedetomidine for tracheobronchial stent insertion
Scientific Title:Acronym
Comparative study of remifentanil-propofol with dexmedetomidine versus without dexmedetomidine for tracheobronchial stent insertion
Region
| Japan |
Condition
Condition
Patients with tracheobronchial stenosis undergoing tracheobronchial stent insertion under general anesthesia
Classification by specialty
| Pneumology | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of dexmedetomidine for anesthetic management tracheobronchial stent insertion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamics,respiratory condition,sedative condition,total dose of anesthesia,duration of anesthetic induction,duration of emergence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
conventional anesthetic management with propofol and remifentanil
Interventions/Control_2
combined with conventional anesthetic and dexmedetomidine
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
1)Patient undergoing tracheobronchial stent insertion under general anesthesia
2)Patient over 20 years old
3)Written informed consent from the patient
Key exclusion criteria
1)Patients with bradycardia(HR<50/min)
2)Patients with 2 or 3 AVblock
3)Patients with heart failure
4)Patients with nustable angina pectoris
5)Patients with severe liver disfunction
6)Patients with severe renal disfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Akasaka |
Organization
St.Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
2-16-1 Sugao Miyamae-ku,Kawasaki Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St.Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
2-16-1 Sugao Miyamae-ku,Kawasaki Kanagawa
TEL
Homepage URL
Sponsor or person
Institute
St.Marianna University School of Medicine Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine Department of Anesthesiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2010 | Year | 11 | Month | 12 | 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
| 2010 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 12 | Day |
Last modified on
| 2013 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005431
