A Study to Examine Levels of Sedation During Outpatient Colonoscopies

A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00614263

Enrollment

100

Registered

2008-02-13

Start date

2006-03-31

Completion date

2006-12-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient Colonoscopy

Keywords

Colonoscopy, Sedation levels

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results