Exploratory Study of Propofol and Fentanyl Pharmacodynamics

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ethicon Endo-Surgery
• Treatments: Fentanyl; Propofol

Criteria

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