Patient-Controlled Sedation Versus Anesthesiologist-Administered Sedation

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00868920
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Other: patient control of pump
Other: anesthesiologist controlled sedation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary outcome measure is the depth of sedation, [ Time Frame: during colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure is rate of respiratory depression [ Time Frame: during colonoscopy procedure ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868920

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Mandel, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00868920     History of Changes
Other Study ID Numbers: 806514
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 20, 2014