Conscious Sedation
Conditions
Keywords
sedation for EGD and colonoscopy procedures
Brief summary
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
Interventions
DEVICESEDASYS System
propofol sedation with the SEDASYS System
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists (ASA) I and II * male and female * Scheduled for routine colonoscopy or EGD * ≥18 years of age * Able to read, speak, and understand English
Exclusion criteria
* Physical or psychological condition which would impair trial participation, at the discretion of the PI * BMI ≥ 35 * Pregnancy or lactation * Known or suspected hypersensitivity to propofol or fentanyl * Use of a fentanyl patch * Allergies to eggs, egg products soybeans or soy products * Diagnosis of sleep apnea * Gastroparesis * Full stomach at the time of procedure * Participation in any other investigational device or drug study within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms) | <24 hours, i.e., for duration of study procedure |
Secondary
| Measure | Time frame |
|---|---|
| Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC) | assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study |
Countries
United States
Outcome results
None listed