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

University of Pennsylvania1 site in 1 country50 target enrollmentJanuary 2008

ConditionsColonoscopy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colonoscopy
Sponsor: University of Pennsylvania
Enrollment: 50
Locations: 1
Primary Endpoint: The primary outcome measure is the depth of sedation,
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

March 2009

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

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