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

Comparison of safety of benzodiazepines for moderate sedation during endoscopic submucosal dissection - Comparison of benzodiazepines in sedation during ESD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054966

Enrollment

1000

Registered

2024-07-20

Start date

2024-05-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The incidence of deep sedation.	—

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Countries

Japan

Contacts

Public ContactJun Takada

Gifu University Graduate School of Medicine Department of Gastroenterology

jun_yuri1_1@yahoo.co.jp0582306308

Outcome results