Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

Completed · Not applicable

Conditions studied: Colonoscopy

In brief

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.

Key facts

Study ID

NCT00868920

Run by

University of Pennsylvania

People needed

50

Starts

2008-01-01

Expected to finish

2009-03-01

Last updated by the study team

2017-11-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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