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

JRCT ID: jRCTs031200018

Registered date:20/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: OGIB, Small bowel stenosis, small bowel tumor, inflammatory bowel disease
• Date of first enrollment: 20/04/2020
• Target sample size: 72
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Proper sedation rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakakibara Yuko
• Source(s) of Monetary Support: National Hospital Organization operating expenses grant research expenses