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Completed

NCT Number: NCT00452426

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

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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Key information

Conditions

Colonoscopy Conscious Sedation Endoscopy, Digestive System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Metropolitan Gastroenterology Group, PC, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

propofol sedation per device instructions for use

benzodiazepines and opioid sedation

Other

per site's current standard of care

Primary outcomes

  1. Area Under the Curve for Oxygen Desaturation (AUCDesat)

    Time frame: From administration of initial drug dose until subject recovered from effects of sedation

    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.

Secondary outcomes

  1. Duration of Deep Sedation/General Anesthesia

    Time frame: From first dose until subject recovered from effects of sedation

    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.

  2. Patient Satisfaction

    Time frame: 24-48 hours post sedation

    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.

  3. Clinician Satisfaction

    Time frame: Post procedure

    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.

  4. Recovery Time (From Sedation)

    Time frame: from "scope out" until first of two consecutive MOAA/S scores of 5

    Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 27, 2007
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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