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Exploratory Study of Propofol and Fentanyl Pharmacodynamics

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ClinicalTrials.gov Identifier: NCT01550770
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Description
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Brief Summary:
Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.

Condition or disease Intervention/treatment Phase
General Anesthesia Drug: propofol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
Experimental: proprofol Drug: propofol
peripheral IV of propofol at increasing dose levels


Outcome Measures
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Primary Outcome Measures :
  1. Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES) [ Time Frame: 1 day ]
    MOAAS and TES assessment of increasing level(s) of sedation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesia (ASA) classification score I-II male and female volunteers
  • Normal healthy individual by medical history and physical examination
  • Uncomplicated airway anatomy
  • Body Mass Index (BMI) between 18-29
  • Subject willing to give consent and comply with evaluation and treatment schedule
  • 18-55 years of age (inclusive)
  • Negative durg screen for marijuana, cocaine, ecstasy, phencyclidine (PCP), amphetamines, benzodiazepines, opiates and methamphetamines
  • Woman of childbearing age byst be utilizing reliable means of contraception
  • Able to read, speak and understand English

Exclusion Criteria:

  • Physical of psychological condition which would impair study participation as determined by the principal investigator
  • Known or suspected neurological pathologies as assessed by the principal investigator
  • History of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter pharmacokinetics or pharmacodynamics of fentanyl and/or propofol
  • Known or suspected hypersensitivity to any study drug
  • Taken any medication within 2 days prior to study drug administration, with the exception of oral contraceptives
  • Baseline tolerance above 50 mA on TES
  • Pregnancy or lactation
  • Consumed food within 8 hours or liquids within 4 hours prior to study drug administration
  • Participation in any other investigational device or durg study within 30 days of enrollment
  • Diagnosis of sleep apnea
  • Current prescription to anti-depressant or anti-anxiety medication
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550770


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
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Principal Investigator: Talmage Egan, MD University of Utah
More Information
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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01550770    
Other Study ID Numbers: CI-10-0005
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics