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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: proprofol	Drug: propofol; peripheral IV of propofol at increasing dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES)	MOAAS and TES assessment of increasing level(s) of sedation	1 day

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Talmage Egan, MD, University of Utah

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: CI-10-0005