Exploratory Study of Propofol and Fentanyl Pharmacodynamics

General Anesthesia Clinical Trial

Official title:

An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550770
• Other study ID #: CI-10-0005
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2012
• Last updated: July 20, 2012
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• propofol
peripheral IV of propofol at increasing dose levels

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No