UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials on sedation for endoscopy
Acronym	Sedation test for endoscopy
Scientific Title	Clinical efficacy of drugs used for sedation during endoscopy and factors related to efficacy and adverse events - A single-center prospective study
Scientific Title:Acronym	Sedation study
Region	Japan

Condition
Condition	Upper digestive tract disorder
Classification by specialty	Hepato-biliary-pancreatic medicine Anesthesiology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To compare the efficacy of midazolam and flunitrazepam for sedation during endoscopy and to identify factors related to efficacy and adverse events.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the rate of achieving adequate sedation (anesthesia) depth after 5 minutes of administration of midazolam and flunitrazepam
Key secondary outcomes	1) Correlation between depth of sedation (anesthesia) and blood concentration of drugs 2) Correlation between depth of sedation (anesthesia) and genetic polymorphisms of drug metabolizing enzymes, MDR1 and GABRA1 3) Correlation of drug metabolizing enzymes, MDR1 and GABRA1 gene polymorphisms with depression 4) Comparison of cardiovascular and respiratory status between midazolam and flunitrazepam 5) Correlation of blood drug concentrations between midazolam and flunitrazepam 6) Comparison of patient satisfaction between midazolam and flunitrazepam 7) Comparison of recovery time between midazolam and flunitrazepam 8) Safety 9) Frequency of depression and side effects

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patients undergoing upper gastrointestinal endoscopy, whether as an outpatient or inpatient (2) Patients who have received sufficient explanation and understanding of the study, and have given their free written consent to participate in the study. (3) Patients must be 20 years old or older and Japanese, regardless of gender.
Key exclusion criteria	(1) Patients with a history of allergy to sedatives (2) Patients with hepatic cirrhosis or dialysis that may affect metabolism. (3) Patients suffering from psychiatric disorders that may affect the sedative effect and patients taking two or more psychotropic drugs. (4) Women who are pregnant, lactating, or who wish to become pregnant during the study
Target sample size	355

Research contact person
Name of lead principal investigator	1st name Tomomi Middle name Last name Yamashima
Organization	Fukuoka University
Division name	gastroenterology
Zip code	8140180
Address	45-1, Nanakuma 7-chome, Jonan-ku, Fukuoka City, Fukuoka Prefecture
TEL	092-801-1011
Email	t.yamashima.bl@adm.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Yamashima
Organization	University of Fukuoka
Division name	gastroenterology
Zip code	8140180
Address	45-1, Nanakuma 7-chome, Jonan-ku, Fukuoka City, Fukuoka Prefecture
TEL	092-801-1011
Homepage URL
Email	t.yamashima.bl@adm.fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Fukuoka University
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	Fukuoka University
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel	092-801-1011
Email	rinshou@adm.fukuoka-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	2022 Year 03 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	Preinitiation
Date of protocol fixation	2022 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is a single-center prospective study in which patients will be divided into two groups according to whether midazolam or flunitrazepam was used during upper gastrointestinal endoscopy. The subjects will be recruited from patients who visited our facility between March 2022 and March 2023, and all patients who meet the selection criteria will be explained about the study and given consent. Vital signs, blood concentration at 5 minutes after drug administration, drug-metabolizing enzymes, depth of anesthesia, and patient satisfaction after completion of the examination will be evaluated.

Management information
Registered date	2022 Year 02 Month 08 Day
Last modified on	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053408