A Study to Examine Levels of Sedation During Outpatient Colonoscopies

Completed

• Conditions: Outpatient Colonoscopy

• Registration Number: NCT00614263
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-03
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Baylor University Medical Center - Department of Anesthesiology; 🇺🇸 Dallas, Texas, United States