Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

PHASE2CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Gastrointestinal EndoscopyGastrointestinal Polypectomy
Interventions
DRUG

Placebo

Infusion of placebo, same infusion rates as for arm 2

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute

DRUG

ICI35,868 (propofol)

Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Trial Locations (2)

Unknown

Research Site, Isesaki

Research Site, Moriya

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson K.K. Medical Company

INDUSTRY

lead

AstraZeneca

INDUSTRY