Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Other: patient control of pump; Other: anesthesiologist controlled sedation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.
Experimental: 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure is the depth of sedation,	during colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary outcome measure is rate of respiratory depression	during colonoscopy procedure

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Jeff E Mandel, MD MS, University of Pennsylvania, Anesthesia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 806514