CompletedPhase 3

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

United States1,000 participantsStarted 2007-03

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Curve for Oxygen Desaturation (AUCDesat)

Timeframe: From administration of initial drug dose until subject recovered from effects of sedation

Trial details

NCT IDNCT00452426

SponsorEthicon Endo-Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

Results submitted2010-10-06

View on ClinicalTrials.gov More Colonoscopy trials