drugset / Trial / NCT02532647
Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy
RandomizedParallel-groupDouble-blindSupportive care
Summary
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in American Society of Anesthesiologists (ASA) Grade III and IV patients (ASA status evaluated by an anesthesiologist not otherwise involved in the study) undergoing a colonoscopy for diagnostic or therapeutic reasons.
Timeline
- Start
- 2015-11
- Primary completion
- 2016-12
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midazolam | Small molecule | 0.5 mg | — |
| Subject | Remimazolam | Small molecule | 1.25 mg | — |
| Subject | Remimazolam | Small molecule | 2.5 mg | — |
Indications
No indication recorded.