Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

NCT ID: NCT00868920

Last Updated: 2017-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

patient control of pump

Intervention Type: OTHER

Patient controls sedation pump during colonoscopy.

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.

Group Type: EXPERIMENTAL

anesthesiologist controlled sedation

Intervention Type: OTHER

Anesthesiologist will control the sedation pump during colonoscopy.

Interventions

patient control of pump

Patient controls sedation pump during colonoscopy.

Intervention Type: OTHER

anesthesiologist controlled sedation

Anesthesiologist will control the sedation pump during colonoscopy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff E Mandel, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Anesthesia

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20493481 (View on PubMed)

Other Identifiers

806514

Identifier Type: -

Identifier Source: org_study_id