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A Study to Examine Levels of Sedation During Outpatient Colonoscopies

Baylor Scott and White Health (BSWH) logo

Baylor Scott and White Health (BSWH)

Status

Completed

Conditions

Outpatient Colonoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT00614263
006-005

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

100 participants in 2 patient groups

Blinded Group
Description:
SEDline output is unknown to anesthesiologist.
Unblinded Group
Description:
SEDline output is known to anesthesiologist.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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