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
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: NCT01550770

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

No publications provided

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:
Fentanyl
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 24, 2014