Randomized controlled trial examining the usefulness and safety of midazolam continuous intravenous infusion and pethidine hydrochloride in small intestine endoscope

Randomized controlled trial examining the usefulness and safety of midazolam continuous intravenous infusion and pethidine hydrochloride in small intestine endoscope - NHOG-MDZ-GFCF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200018

Enrollment

Registered

2020-04-20

Start date

2020-04-20

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

OGIB, Small bowel stenosis, small bowel tumor, inflammatory bowel disease OGIB, small intestine, inflammatory bowel disease, small intestine endoscope

Interventions

Midazolam single intravenous + pethidine hydrochloride combination Midazolam continuous intravenous infusion + pethidine hydrochloride combination

Midazolam single intravenous, Midazolam continuous intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with small intestine endoscopy and treatment for more than 1 hour (2) Patients with ECOG PS 0-2 (3) Patients who are over 20 years old at the time of obtaining consent (4) Patients whose written consent was obtained by the patient's own free will

Exclusion criteria

Exclusion criteria: (1) American Society of Anesthesiologists physical status classification (ASA-PS) 4 or more patients (2) Patients with heart failure (New York Heart Association: NYHA) grade 4 (3) Respiratory failure (Fletcher-Huge-jones classification) Grade 5 patients (4) Child-Pugh classification grade C patients (5) Women who are or may be pregnant (6) Patients who are allergic to the drugs used (7) Patients taking HIV protease inhibitor, efavirenz, and cobicistat-containing drugs (8) Patients with myasthenia gravis and acute narrow-angle glaucoma (9) In the event that the investigator or research investigator determines that participation in this study is not appropriate

Design outcomes

Primary

Measure	Time frame
Proper sedation rate	—

Secondary

Measure	Time frame
1) Proportion of body movements that require testing / treatment interruption 2) Satisfaction level (surgeon, research subject) 3) Amount of midazolam and pethidine hydrochloride used 4) Proportion of serious adverse events 5) Proportion of test suspension including presence or absence of additional drugs	—

Contacts

Public ContactYuko Sakakibara

National Hospital Organization Osaka National Hospital

sakakibara.yuko.cp@mail.hosp.go.jp+81-6-6942-1331

Outcome results

None listed

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