Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Other: anesthesiologist controlled sedation; Other: patient control of pump

• Registration Number: NCT00868920
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	anesthesiologist controlled sedation	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.
1	patient control of pump	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the depth of sedation,	during colonoscopy procedure

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measure is rate of respiratory depression	during colonoscopy procedure

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States