Exploratory Study of Propofol and Fentanyl Pharmacodynamics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01550770
First received: March 5, 2012
Last updated: July 20, 2012
Last verified: July 2012

March 5, 2012
July 20, 2012
February 2012
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01550770 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exploratory Study of Propofol and Fentanyl Pharmacodynamics
An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
General Anesthesia
Drug: propofol
peripheral IV of propofol at increasing dose levels
Experimental: proprofol
Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01550770
CI-10-0005
Not Provided
Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: Talmage Egan, MD University of Utah
Ethicon Endo-Surgery
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP