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OpenTrials
Completed

NCT Number: NCT01550770

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

peripheral IV of propofol at increasing dose levels

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2012
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.