Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colonoscopy

Intervention / Treatment
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* Other: patient control of pump
* Other: anesthesiologist controlled sedation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Patient controls sedation pump during colonoscopy.<br>|
| Experimental: 2<br>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<br>* Anesthesiologist will control the sedation pump during colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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