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Exploratory Study of Propofol and Fentanyl Pharmacodynamics

NCT ID: NCT01550770

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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proprofol

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

peripheral IV of propofol at increasing dose levels

Interventions

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propofol

peripheral IV of propofol at increasing dose levels

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Talmage Egan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CI-10-0005

Identifier Type: -

Identifier Source: org_study_id