Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Ethicon

Status and phase

Completed

Phase 1

Conditions

General Anesthesia

Treatments

Drug: propofol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01550770

CI-10-0005

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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