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

Ethicon

Status and phase

Completed

Phase 3

Conditions

Conscious Sedation

Endoscopy, Digestive System

Colonoscopy

Treatments

Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)

Other: benzodiazepines and opioid sedation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452426

CI-06-0004

Details and patient eligibility

About

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.

Enrollment

1,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.