Phase 3 N=1,000 Randomized Screening

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

Colonoscopy · Endoscopy, Digestive System · Conscious Sedation

Bottom Line

View on ClinicalTrials.gov: NCT00452426 ↗

Enrolled (actual)

1,000

Serious AEs

0.1%

Results posted

Jan 2011

Primary outcome: Primary: Area Under the Curve for Oxygen Desaturation (AUCDesat) — 23.6; 88.0 seconds*percent of oxygen desaturation — p=0.028

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) (Device); benzodiazepines and opioid sedation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon Endo-Surgery
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve for Oxygen Desaturation (AUCDesat)	23.6; 88.0	0.028 sig
SECONDARY Duration of Deep Sedation/General Anesthesia	0.1; 0.1	—
SECONDARY Patient Satisfaction	92.3; 89.7	0.007 sig
SECONDARY Clinician Satisfaction	92.2; 76.3	<0.001 sig
SECONDARY Recovery Time (From Sedation)	2.9; 6.5	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00452426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.