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Clinical Trials/NCT00614263
NCT00614263
Completed
Not Applicable

A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies

Baylor Research Institute1 site in 1 country100 target enrollmentMarch 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Outpatient Colonoscopy
Sponsor
Baylor Research Institute
Enrollment
100
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
December 2006
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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