Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868920
• Other study ID #: 806514
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: November 28, 2017
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• patient control of pump
Patient controls sedation pump during colonoscopy.
• anesthesiologist controlled sedation
Anesthesiologist will control the sedation pump during colonoscopy.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the depth of sedation,		during colonoscopy procedure
Secondary	The secondary outcome measure is rate of respiratory depression		during colonoscopy procedure