Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Keywords: sedation, propofol, gastrointestinal endoscopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 279
Healthy volunteers: no

Brief summary:
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.

The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.

Detailed description:

Arms:
arm 1: Group 1 (placebo group) is treated by Anaesthesiologist arm 2: Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist arm 3: Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist

Interventions: intervention 1: Intralipid intervention 2: ICI35,868 (Diprivan) intervention 3: ICI35,868 (Diprivan) + EES0000645/A (SDS)
Intervention descriptions: intervention 1: Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.) intervention 2: Treated by Anaesthesiologist intervention 3: Treated by Endoscopist with EES0000645/A(SDS)

Protocol document: