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A Study to Examine Levels of Sedation During Outpatient Colonoscopies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00614263
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
Examine levels of sedation required for patients to comfortably undergo colonoscopy using propofol and if adjunct monitoring equipment promotes patient safety.

Condition or disease
Outpatient Colonoscopy

Detailed Description:

Propofol for sedation during outpatient endoscopy has become a popular technique in place of midazolam and opioid sedation. It has been associated with improved patient satisfaction and a faster recovery with less nausea and vomiting. However, there are a number of potential adverse effects associated with propofol. It has no analgesic effects; therefore, when used for moderate sedation procedures it frequently has to provide deeper levels of sedation to allow a painful procedure to be performed.

Some patients are sedated to the level of general anesthesia and may develop respiratory depression or airway obstruction requiring immediate airway support.

We examined the level of sedation required for patients to comfortably undergo routine colonoscopy using propofol and what monitoring system would best predict the patients who might need an airway intervention.


Study Type : Observational
Actual Enrollment : 100 participants
Official Title: A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies
Study Start Date : March 2006
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Group/Cohort
Blinded Group
SEDline output is unknown to anesthesiologist.
Unblinded Group
SEDline output is known to anesthesiologist.



Primary Outcome Measures :
  1. Examine possible relationships (correlations) between sedation using the SEDLine monitors and level of sedation using the Ramsay Sedation Scale and examine the number and type of airway interventions and clinical signs performed during the procedure. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
Outpatient GI clinic
Criteria

Inclusion Criteria:

  • Greater than 18 years of age
  • ASA classification of I, II, or III

Exclusion Criteria:

  • Anesthesiologist plans to use a combination of medications other than propofol for sedation.
  • ASA classification IV or higher
  • Lesions on forehead or earlobes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614263


Locations
United States, Texas
Baylor University Medical Center - Department of Anesthesiology
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Michael Ramsay, MD Baylor Research Institute

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00614263     History of Changes
Other Study ID Numbers: 006-005
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Baylor Research Institute:
Colonoscopy
Sedation levels