Randomized controlled trial examining the usefulness and safety of midazolam continuous intravenous infusion and pethidine hydrochloride in small intestine endoscope
- Conditions
- OGIB, Small bowel stenosis, small bowel tumor, inflammatory bowel diseaseOGIB, small intestine, inflammatory bowel disease, small intestine endoscope
- Registration Number
- JPRN-jRCTs031200018
- Lead Sponsor
- Sakakibara Yuko
- Brief Summary
In this study, we compared the efficacy and safety of "continuous intravenous midazolam plus pethidine hydrochloride" (new group) with those of "intermittent midazolam plus pethidine hydrochloride" (standard group) in small bowel endoscopy. The new group tended to have less body movement, but was not superior to the standard group. Given the acceptable safety profile of both groups and the paucity of similar studies, continuous infusion may be considered an option for sedation in some patient populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 76
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proper sedation rate
- Secondary Outcome Measures
Name Time Method 1) Proportion of body movements that require testing / treatment interruption<br>2) Satisfaction level (surgeon, research subject)<br>3) Amount of midazolam and pethidine hydrochloride used<br>4) Proportion of serious adverse events<br>5) Proportion of test suspension including presence or absence of additional drugs