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OpenTrials
Completed

NCT Number: NCT00868920

Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient control of pump

Other

Patient controls sedation pump during colonoscopy.

anesthesiologist controlled sedation

Other

Anesthesiologist will control the sedation pump during colonoscopy.

Primary outcomes

  1. The primary outcome measure is the depth of sedation,

    Time frame: during colonoscopy procedure

Secondary outcomes

  1. The secondary outcome measure is rate of respiratory depression

    Time frame: during colonoscopy procedure

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2009
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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