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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452426
• Other study ID #: CI-06-0004
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2007
• Last updated: December 30, 2010
• Start date: March 2007
• Est. completion date: October 2007

Study information

• Verified date: December 2010
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colonoscopy
• Conscious Sedation
• Endoscopy, Digestive System

Intervention

Device:
• Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
propofol sedation per device instructions for use

Other:
• benzodiazepines and opioid sedation
per site's current standard of care

Locations

Country	Name	City	State
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Fayetteville Gastroenterology Associates, PA	Fayetteville	North Carolina
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Digestive Health Specialists	Tacoma	Washington
United States	Metropolitan Gastroenterology Group, PC	Washington	District of Columbia
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve for Oxygen Desaturation (AUCDesat)	AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.	From administration of initial drug dose until subject recovered from effects of sedation	Yes
Secondary	Duration of Deep Sedation/General Anesthesia	Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.	From first dose until subject recovered from effects of sedation	No
Secondary	Patient Satisfaction	Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.	24-48 hours post sedation	No
Secondary	Clinician Satisfaction	Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.	Post procedure	No
Secondary	Recovery Time (From Sedation)	Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.	from "scope out" until first of two consecutive MOAA/S scores of 5	No