Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation
Not Applicable
Completed
- Conditions
- Colonoscopy
- Registration Number
- NCT00868920
- Lead Sponsor
- University of Pennsylvania
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary outcome measure is the depth of sedation, during colonoscopy procedure
- Secondary Outcome Measures
Name Time Method The secondary outcome measure is rate of respiratory depression during colonoscopy procedure
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United States