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Clinical Trials/JPRN-jRCTs031200018
JPRN-jRCTs031200018
Completed
Phase 4

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

Sakakibara Yuko0 sites76 target enrollmentApril 20, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
OGIB, Small bowel stenosis, small bowel tumor, inflammatory bowel disease
Sponsor
Sakakibara Yuko
Enrollment
76
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
who.int
Start Date
April 20, 2020
End Date
October 10, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sakakibara Yuko

Eligibility 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

  • (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

Outcomes

Primary Outcomes

Not specified

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