A Study to Examine Levels of Sedation During Outpatient Colonoscopies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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

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Safety Issues

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Detailed Description

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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.

Conditions

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Outpatient Colonoscopy

Study Groups

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Blinded Group

SEDline output is unknown to anesthesiologist.

No interventions assigned to this group

Unblinded Group

SEDline output is known to anesthesiologist.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No