UMIN-CTR Clinical Trial

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
Email	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
Email	ttpcx442@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042442