Exploratory Study of Propofol and Fentanyl Pharmacodynamics

This study has been completed.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
First received: March 5, 2012
Last updated: July 20, 2012
Last verified: July 2012
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 Intervention Phase
General Anesthesia
Drug: propofol
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Resource links provided by NLM:

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    MOAAS and TES assessment of increasing level(s) of sedation

Enrollment: 20
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: proprofol Drug: propofol
peripheral IV of propofol at increasing dose levels


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01550770

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Ethicon Endo-Surgery
Principal Investigator: Talmage Egan, MD University of Utah
  More Information

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01550770     History of Changes
Other Study ID Numbers: CI-10-0005 
Study First Received: March 5, 2012
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Hypnotics and Sedatives
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016