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CompletedNCT01550770Updated Jul 23, 2012

Exploratory Study of Propofol and Fentanyl Pharmacodynamics

A Phase 1 interventional study of propofol in General Anesthesia, sponsored by Ethicon Endo-Surgery. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-23.

Sponsored by Ethicon Endo-Surgery · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • General Anesthesia
03

In context

Lead sponsor

Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    proprofol

    Drug: propofol

Interventions

  • Drugpropofol

    peripheral IV of propofol at increasing dose levels

06

What researchers measure

Primary outcomes

  1. Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES)

    MOAAS and TES assessment of increasing level(s) of sedation

    Time frame: 1 day

07

Study locations

1 site
  • University of Utah
    Salt Lake City, Utah 84132, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01550770
Lead sponsor
Ethicon Endo-Surgery
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Feb 2012
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Jul 23, 2012

Study contacts

Talmage Egan, MD
principal investigator · University of Utah
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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