Conditions: Colonoscopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 461
Healthy volunteers: no

Brief 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 patients undergoing a colonoscopy for diagnostic or therapeutic reasons.

Detailed description:

Arms:
arm 1: Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses arm 2: Inactive control arm

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses arm 3: Midazolam iv 1.75 mg\* for sedation induction and 1.0 mg\* for sedation maintenance.

\*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses

Interventions: intervention 1: Remimazolam intervention 2: Midazolam intervention 3: Placebo
Intervention descriptions: intervention 1: For induction and maintenance of sedation intervention 2: For induction of maintenance and sedation intervention 3: Inactive control arm

Protocol document: