CompletedNot Applicable

Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

United States50 participantsStarted 2008-01

Plain-language summary

The purpose of this study is to see whether patients controlling their own sedation during colonoscopy are less likely to need help breathing than when an anesthesiologist controls the medicine, and whether we can predict when the need for help will occur. The pump used in the study is approved for clinical use by the FDA, as are the medicines used in the pump.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Undergoing elective, outpatient colonoscopy
✓. Age ≥ 18, \<90
✓. Meet criteria for conscious sedation (HUP Policy 1-12-11, Appendix F), as determined by the attending gastroenterologist and confirmed by the anesthesiologist by review of history
✓. Able to give informed consent

Exclusion criteria

✕. Have a history of allergy or adverse reaction to propofol or remifentanil
✕. Have a condition which would pose an elevated risk for administration of propofol, including primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
✕. Female of child-bearing potential (under 50 without surgical sterilization)
✕. Unable to understand the use of Patient Contolled Sedation

What they're measuring

The primary outcome measure is the depth of sedation,

Timeframe: during colonoscopy procedure

Trial details

NCT IDNCT00868920

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Colonoscopy trials