Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

NCT00868920 | Completed DMC

• 1 other identifier: 806514
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the depth of sedation,

  during colonoscopy procedure

Secondary Outcomes (1)

• The secondary outcome measure is rate of respiratory depression

  during colonoscopy procedure

Study Arms (2)

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

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

Interventions

patient control of pump OTHER

Patient controls sedation pump during colonoscopy.

1

anesthesiologist controlled sedation OTHER

Anesthesiologist will control the sedation pump during colonoscopy.

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Mandel JE, Lichtenstein GR, Metz DC, Ginsberg GG, Kochman ML. A prospective, randomized, comparative trial evaluating respiratory depression during patient-controlled versus anesthesiologist-administered propofol-remifentanil sedation for elective colonoscopy. Gastrointest Endosc. 2010 Jul;72(1):112-7. doi: 10.1016/j.gie.2010.01.031. Epub 2010 May 20.

  PMID: 20493481 DERIVED

Study Officials

• Jeff E Mandel, MD MS

  University of Pennsylvania, Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

US (1)