UMIN-CTR Clinical Trial

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

Upper digestive tract disorder

Classification by specialty

Hepato-biliary-pancreatic medicine	Anesthesiology	Adult

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukuoka University

Institute

Department

Personal name

Organization

Fukuoka University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2022

Year

02

Month

08

Day

Last modified on

2022

Year

02

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053408