A Study to Examine Levels of Sedation During Outpatient Colonoscopies - Full Text View

Sponsored by:	Baylor Research Institute
Information provided by:	Baylor Research Institute
ClinicalTrials.gov Identifier:	NCT00614263

Purpose

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

Condition
Outpatient Colonoscopy

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:

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. [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	100
Study Start Date:	March 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
2
A Blinded group, the anesthesiologist was blinded to the SEDLine output and in the unblinded group, the anesthesiologist was privy to the SEDLine output

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614263

Locations

United States, Texas
Baylor University Medical Center - Department of Anesthesiology
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Baylor Research Institute

More Information

Responsible Party:	Baylor Research Institute ( Dr. Michael A. E. Ramsay, MD, FRCA )
Study ID Numbers:	Baylor IRB 006-005
Study First Received:	January 31, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00614263
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor Research Institute:

Colonoscopy
Sedation levels

ClinicalTrials.gov processed this record on January 14, 2009