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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Johnson & Johnson K.K. Medical Company
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Male or female (females of child bearing potential to confirm not pregnant via test or contraception)

• Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) grade III, IV V and VI

• Baseline oxygen saturation<90% (room air)

• Body Mass Index (BMI) >=35