UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037225 |
|---|---|
| Receipt number | R000042442 |
| Scientific Title | A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2020/07/03 17:33:34 |
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Basic information
Public title
A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases
Acronym
A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases
Scientific Title
A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases
Scientific Title:Acronym
A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases
Region
| Japan |
Condition
Condition
patients with postoperative reconstructed intestine who are scheduled to be performed DB-ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the sedation during DB-ERCP, we compare body movement occurrence rates in the group using and not using BIS monitor, and verify the usefulness of BIS monitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The body movement occurrence rates in each group
Key secondary outcomes
1)Occurrence rate of respiratory depression and circulatory failure in each group
2)Inspection interruption rate due to sedation failure in each group
3)Technical success rate in each group
4)Propofol dose in each group
5)Procedure time and anesthesia time in each group
6)Recovery time in each group
7)Risk factors for occurrence of body movement
8)Sedation satisfaction score
9)Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using BIS monitor, consider BIS value: 40-60 as appropriate sedation level and adjust the target blood concentration of propofol.
Interventions/Control_2
Do not use BIS monitor, consider Ramsey Sedation Score: SS 5-6 as the appropriate sedation level and adjust the target blood concentration of propofol.
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 with postoperative reconstructed intestine who are scheduled to be performed DB-ERCP
Key exclusion criteria
1)Patients less than 20 years old
2)Pregnant woman
3)Patients with egg, soy, propofol allergy
4)Patients with hypotension (less than 90/50 mmHg) or bradycardia (less than 50bpm), and patients receiving oxygen prior to sedation
5)Patients with ASA-Performance status 4-6
6)Patients already registered in this study
7)Patients who determined to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Division of Endoscopy
Zip code
700-8558
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Miyamoto |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
ttpcx442@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2019 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042442
