Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care

Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.

Inclusion Criteria:

• ≥ 18 years old
• Able to comprehend, sign, and date the written informed consent form
• English as primary language
• Undergoing a non-emergent EGD or colonoscopy
• Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
• American Society of Anesthesiologists (ASA) Class I, II or III

Exclusion Criteria:

• Allergy or inability to tolerate study medications or components of study medications
• Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
• Currently using a fentanyl patch
• History of diagnosed sleep apnea
• History of diagnosed gastroparesis
• Baseline oxygen saturation < 90% (room air)
• Pregnant or nursing females
• Body mass index (BMI) ≥ 35
• Participation in a clinical trial within the past 30 days.