Colonoscopy
Conditions
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.
Interventions
OTHERpatient control of pump
Patient controls sedation pump during colonoscopy.
OTHERanesthesiologist controlled sedation
Anesthesiologist will control the sedation pump during colonoscopy.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the depth of sedation, | during colonoscopy procedure |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure is rate of respiratory depression | during colonoscopy procedure |
Countries
United States
Outcome results
None listed