UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011443 |
|---|---|
| Receipt number | R000013395 |
| Scientific Title | A randomized trial of propofol versus midazolam of sedation during radio frequency ablation in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2019/02/13 10:33:33 |
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Basic information
Public title
A randomized trial of propofol versus midazolam of sedation during radio frequency ablation in patients with hepatocellular carcinoma
Acronym
A randomized trial of propofol versus midazolam of sedation during radio frequency ablation in patients with hepatocellular carcinoma
Scientific Title
A randomized trial of propofol versus midazolam of sedation during radio frequency ablation in patients with hepatocellular carcinoma
Scientific Title:Acronym
A randomized trial of propofol versus midazolam of sedation during radio frequency ablation in patients with hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of propofol sedation during radio frequency ablation (RFA) compared to midazolam
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient's degree of satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
propofol of sedation
Interventions/Control_2
midazolam of sedation
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) 20 years-old (Gender does not matter).
2) Acquisition of written informed consent.
3) Have been diagnosed with hepatocellular carcinoma.
4)ECOG performance status of 0-1.
5) Child-Pugh A or B.
6) Among patients who fulfill the inclusion criteria.
Key exclusion criteria
1)Patients with sever cardiovascular disorder
2)American Society of Anesthesiologists (ASA)
: 4 or more
3)Body Mass Index (BMI): 30 or more
4)Patients who knwn cotraindications for propfol pr midazolam
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Kato |
Organization
Chiba university hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadahisa Ogasawara |
Organization
Chiba university hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba
TEL
043-222-7171
Homepage URL
sadahisa@me.com
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 08 | Month | 10 | 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 | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013395
