Exploratory Study of Propofol and Fentanyl Pharmacodynamics

NCT01550770 | Completed Phase 1

• 1 other identifier: CI-10-0005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Outcome Measures

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

  1 day

Study Arms (1)

proprofol

EXPERIMENTAL

Drug: propofol

Interventions

propofol DRUG

peripheral IV of propofol at increasing dose levels

proprofol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Talmage Egan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 23, 2012

Record last verified: 2012-07

Locations

US (1)