Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation - Full Text View

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00868920

Purpose

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.

Condition	Intervention	Phase
Colonoscopy	Other: patient control of pump Other: anesthesiologist controlled sedation	Phase IV

MedlinePlus related topics: Colonoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

The primary outcome measure is the depth of sedation, [ Time Frame: during colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome measure is rate of respiratory depression [ Time Frame: during colonoscopy procedure ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	January 2008
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The Graseby 3300 PCA pump will be loaded with a mixture of propofol 10 mg/cc containing 10 µg/cc remifentanil. The loading and demand doses will be individualized based on patient weight, height, age, and gender. The initial loading phase of sedation will be performed by the anesthesiologist to permit estimation of patient sensitivity. Following the initial loading dose, a series of button presses will be issued by the anesthesiologist to achieve a state of moderate sedation, as determined by a decrease in BIS to the range of 75-80. Once this state has been reached, the button will be transferred to the patient for Patient C0ntrolled Sedation.	Other: patient control of pump Patient controls sedation pump during colonoscopy.
2: Experimental The Graseby 3300 PCA pump will be loaded with a mixture of propofol 10 mg/cc containing 10 µg/cc remifentanil. The loading and demand doses will be individualized based on patient weight, height, age, and gender. The initial loading phase of sedation will be performed by the anesthesiologist to permit estimation of patient sensitivity. Following the initial loading dose, a series of button presses will be issued by the anesthesiologist to achieve a state of moderate sedation, as determined by a decrease in BIS to the range of 75-80. Once this state has been reached,the anesthesiologist will control the sedation.	Other: anesthesiologist controlled sedation Anesthesiologist will control the sedation pump during colonoscopy.

Arms

Assigned Interventions

1: Experimental

The Graseby 3300 PCA pump will be loaded with a mixture of propofol 10 mg/cc containing 10 µg/cc remifentanil. The loading and demand doses will be individualized based on patient weight, height, age, and gender. The initial loading phase of sedation will be performed by the anesthesiologist to permit estimation of patient sensitivity. Following the initial loading dose, a series of button presses will be issued by the anesthesiologist to achieve a state of moderate sedation, as determined by a decrease in BIS to the range of 75-80. Once this state has been reached, the button will be transferred to the patient for Patient C0ntrolled Sedation.

Other: patient control of pump

Patient controls sedation pump during colonoscopy.

2: Experimental

The Graseby 3300 PCA pump will be loaded with a mixture of propofol 10 mg/cc containing 10 µg/cc remifentanil. The loading and demand doses will be individualized based on patient weight, height, age, and gender. The initial loading phase of sedation will be performed by the anesthesiologist to permit estimation of patient sensitivity. Following the initial loading dose, a series of button presses will be issued by the anesthesiologist to achieve a state of moderate sedation, as determined by a decrease in BIS to the range of 75-80. Once this state has been reached,the anesthesiologist will control the sedation.

Other: anesthesiologist controlled sedation

Anesthesiologist will control the sedation pump during colonoscopy.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868920

Locations

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

More Information

No publications provided

Responsible Party:	University of Pennsylvania ( Jeff Mandel, MD )
Study ID Numbers:	806514
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00868920 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Remifentanil
Propofol

ClinicalTrials.gov processed this record on May 07, 2009