A Study to Examine Levels of Sedation During Outpatient Colonoscopies
|Official Title:||A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies|
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
SEDline output is unknown to anesthesiologist.
SEDline output is known to anesthesiologist.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614263
|United States, Texas|
|Baylor University Medical Center - Department of Anesthesiology|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Michael Ramsay, MD||Baylor Research Institute|