UMIN-ICDS Clinical Trial

Public title

Comparison of safety of diazepam and midazolam for moderate sedation during gastric endoscopic submucosal dissection

Acronym

Comparison of benzodiazepines in sedation during ESD

Scientific Title

Comparison of safety of benzodiazepines for moderate sedation during endoscopic submucosal dissection

Scientific Title:Acronym

Comparison of benzodiazepines in sedation during ESD

Region

Japan

Condition

Gastric tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In Japan, benzodiazepine sedatives are widely used during long endoscopic procedures, including ESD, but there is no clear evidence regarding the choice of drug. Since both diazepam and midazolam have been used for sedation during endoscopy for some time, it is assumed that both can be used safely, but by presenting which is more effective, safer, or equivalent through this study, we hope to build evidence for appropriate benzodiazepine drug selection during therapeutic endoscopy in Japan. This study is expected to provide evidence for the selection of appropriate benzodiazepines for therapeutic endoscopy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The incidence of deep sedation.

Key secondary outcomes

(1) The proportion of patients who maintained moderate sedation during procedure, (2) oxygen desaturation, defined as a SpO2 drop of 5% or more, or increased oxygen supplementation. (3) incidence of bradypnea, defined as respiratory rate < 8 breaths/min. (4) incidence of blood pressure (BP) reduction, defined as a drop in systolic BP greater than 30% of the baseline value. (5) incidence of bradycardia, defined as heart rate < 50 beats/min. (6) incidence of ESD-related pneumonia.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Consecutive patients who underwent ESD for gastric neoplasms at Gifu University Hospital in Japan between January 2015 and March 2024 were enrolled.

Key exclusion criteria

Patients classified as Class 4 of American Society of Anesthesiologists Physical Status (ASA-PS) Classification System were not indicated.

Target sample size

1000

Name of lead principal investigator

1st name	Jun
Middle name
Last name	Takada

Organization

Gifu University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

501-1194

Address

1-1 Yanagido, Gifu, Japan

TEL

0582306308

Email

jun_yuri1_1@yahoo.co.jp

Name of contact person

1st name	Jun
Middle name
Last name	Takada

Organization

Gifu University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

501-1194

Address

1-1 Yanagido, Gifu, Japan

TEL

0582306308

Homepage URL

Email

jun_yuri1_1@yahoo.co.jp

Institute

Gifu University Graduate School of Medicine

Institute

Department

Personal name

Organization

Gifu University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gifu University Graduate School of Medicine

Address

1-1 Yanagido, Gifu, Japan

Tel

0582306059

Email

rinri@t.gifu-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

2024

Year

07

Month

20

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

2024

Year

05

Month

01

Day

Date of IRB

2024

Year

05

Month

08

Day

Anticipated trial start date

2024

Year

05

Month

08

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

All patients who underwent endoscopic submucosal dissection (ESD) for upper gastrointestinal lesions under moderate sedation with benzodiazepines at Gifu University Hospital were included in the study; patient and lesion background, type and amount of sedative used, Data on procedure duration, vital signs (blood pressure, pulse, oxygen saturation, respiratory rate, etc.) and their changes before and during the procedure, sedation level, use of antagonists, and presence of postoperative pneumonia were collected from medical records and reviewed.

Registered date

2024

Year

07

Month

15

Day

Last modified on

2024

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062795