Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 12/2/2017 |
| Start Date: | January 2008 |
| End Date: | March 2009 |
A Phase IV, Randomized, Double-Blind, Controlled Study of the Effects of Patient-Controlled Sedation vs. Anesthesiologist-Administered Sedation With Propofol and Remifentanil on Rate of Disordered Breathing in Subjects Undergoing Elective Colonoscopy
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.
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.
Inclusion Criteria:
1. Undergoing elective, outpatient colonoscopy
2. Age ≥ 18, <90
3. 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
4. Able to give informed consent
Exclusion Criteria:
1. Have a history of allergy or adverse reaction to propofol or remifentanil
2. Have a condition which would pose an elevated risk for administration of propofol,
including primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
3. Female of child-bearing potential (under 50 without surgical sterilization)
4. Unable to understand the use of Patient Contolled Sedation
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