Conditions: Gastrointestinal Endoscopy Gastrointestinal Polypectomy
Keywords: propofol endoscopy sedation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: Placebo intervention 2: ICI35,868 (propofol) intervention 3: ICI35,868 (propofol) intervention 4: ICI35,868 (propofol) intervention 5: ICI35,868 (propofol) intervention 6: ICI35,868 (propofol) intervention 7: ICI35,868 (propofol)
Intervention descriptions: intervention 1: Infusion of placebo, same infusion rates as for arm 2 intervention 2: Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute intervention 3: Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute intervention 4: Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute intervention 5: Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute intervention 6: Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute intervention 7: Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Protocol document: