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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonoscopy Endoscopy, Digestive System Conscious Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Sedation System

Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation

Group Type EXPERIMENTAL

Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)

Intervention Type DEVICE

propofol sedation per device instructions for use

Current Standard of Care

Site's current standard used for delivery of sedation

Group Type ACTIVE_COMPARATOR

benzodiazepines and opioid sedation

Intervention Type OTHER

per site's current standard of care

Interventions

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Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)

propofol sedation per device instructions for use

Intervention Type DEVICE

benzodiazepines and opioid sedation

per site's current standard of care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No