Clinical trial NCT00452426: Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Endoscopy, Digestive System
Conscious Sedation
Keywords: Propofol
Diprivan
Colonoscopy
Endoscopy, Digestive System
Conscious Sedation
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve for Oxygen Desaturation (AUCDesat)
timeFrame: From administration of initial drug dose until subject recovered from effects of sedation
Secondary outcomes:
measure: Duration of Deep Sedation/General Anesthesia
timeFrame: From first dose until subject recovered from effects of sedation
measure: Patient Satisfaction
timeFrame: 24-48 hours post sedation
measure: Clinician Satisfaction
timeFrame: Post procedure
measure: Recovery Time (From Sedation)
timeFrame: from "scope out" until first of two consecutive MOAA/S scores of 5
Other outcomes:
Locations:
city: Washington
country: United States
facility: Metropolitan Gastroenterology Group, PC
state: District of Columbia
city: Fayetteville
country: United States
facility: Fayetteville Gastroenterology Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
Study officials:
affiliation: Ethicon Endo-Surgery, Inc.
name: James Martin, PhD
role: STUDY_DIRECTOR
References:
citation: Pambianco DJ, Vargo JJ, Pruitt RE, Hardi R, Martin JF. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18.