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
|Condition or disease|
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|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
SEDline output is unknown to anesthesiologist.
SEDline output is known to anesthesiologist.
- 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 ]
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
|United States, Texas|
|Baylor University Medical Center - Department of Anesthesiology|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Michael Ramsay, MD||Baylor Research Institute|