Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a randomized phase II trial. KDOG0801

Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a randomized phase II trial. KDOG0801 - Sedation in endoscopic submucosal dissection

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001497

Enrollment

138

Registered

2008-11-11

Start date

2008-07-01

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

early gastric cancer, gastric adenoma

Interventions

sedation with propofol sedation with midazolam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with aerly gastric cancer or gastric adenoma planned ESD. pathological diagnosis revealed group III,IV, or V. above 20 years old. ASA classification:I or II. adequate organ function. no allergic episode with midazolam and propofol. written IC obtained from patients.

Exclusion criteria

Exclusion criteria: ASA classification:above III. severe disease in heart, lung, liver, or kidney. allergic episode with midazolam or propofol. women in pregnancy or breast-feeding any other reasosn by which docter judged inappropriate case.

Design outcomes

Primary

Measure	Time frame
the efficacy of sedation enough for endoscopic submucosal dissection.	—

Secondary

Measure	Time frame
the safety of sedation during endoscopic submucosal dissection. the sagety of sadation after endoscopic submucosal dissection.	—

Countries

Japan

Contacts

Public ContactTohru SASAKI

Kitasato University East Hospital Department of gastroenterology

tohrus@t3.rim.or.jp042-748-9111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026