Exploratory Study of Propofol and Fentanyl Pharmacodynamics
This study has been completed.
Sponsor:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01550770
First received: March 5, 2012
Last updated: July 20, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
General Anesthesia |
Drug: propofol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics |
Resource links provided by NLM:
Further study details as provided by Ethicon Endo-Surgery:
Primary Outcome Measures:
- Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES) [ Time Frame: 1 day ] [ Designated as safety issue: No ]MOAAS and TES assessment of increasing level(s) of sedation
| Enrollment: | 20 |
| Study Start Date: | February 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: proprofol |
Drug: propofol
peripheral IV of propofol at increasing dose levels
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ethicon Endo-Surgery |
| ClinicalTrials.gov Identifier: | NCT01550770 History of Changes |
| Other Study ID Numbers: | CI-10-0005 |
| Study First Received: | March 5, 2012 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fentanyl Propofol Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 18, 2013