General Anesthesia
Conditions
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.
Interventions
DRUGpropofol
peripheral IV of propofol at increasing dose levels
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES) | 1 day | MOAAS and TES assessment of increasing level(s) of sedation |
Countries
United States
Outcome results
None listed