Conditions: Sedation
Keywords: CNS 7056 Procedural Sedation Colonoscopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Detailed description:
This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale, and monitoring of adverse events.

Arms:
arm 1: Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 2: Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 3: Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 4: Initial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses

Interventions: intervention 1: A. CNS 7056 intervention 2: B. CNS 7056 intervention 3: C. CNS 7056 intervention 4: D. Midazolam
Intervention descriptions: intervention 1: Initial low dose plus supplemental doses as necessary. intervention 2: Initial intermediate dose plus supplemental doses as necessary. intervention 3: Initial high dose plus supplemental doses as necessary. intervention 4: Initial standardized dose plus supplemental doses as necessary.

Protocol document: