Clinical trial NCT01962285: Neuronal Inertia in Propofol Anesthesia
Official title: Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia
Propofol Pharmacodynamics
Propofol Target Controlled Infusion
Loss of Consciousness and Recovery of Consciousness
Propofol Plasma Concentration
Keywords: neuronal inertia
loss of consciousness
propofol pharmacodynamics
Bispectral index
anesthesia, general/pharmacology
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate, stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

Detailed description: Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves, during a slow, steady-sate, stepped target controlled infusion of Propofol using Schnider's pharmacologic model. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

Eligibility criteria: Inclusion Criteria:

* american society of anesthesiologists status I or II age \>18 years fasted at least 8 hours BMI\<30

Exclusion Criteria:

* any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)

Primary outcomes:
measure: plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml)
timeFrame: 2 hours (during slow steady-state concentration propofol infusion)
Secondary outcomes:
measure: Bispectral Index (BIS) al LOC and ROC
timeFrame: 2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL
measure: Pharmacodynamic curve for propofol.
timeFrame: 2 hours
measure: PROPOFOL effect site concentration during infusion
timeFrame: 2 hours
Other outcomes:
measure: performance of Schnider´s pharmacokinetic parameters in a slow infusion
timeFrame: 2 hours
measure: Electroencephalographic behavior at LOC and ROC during Propofol infusion
timeFrame: 2 hours (during propofol infusion)
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
Study officials:
affiliation: Universidad del Desarrollo
name: pablo sepulveda, anesthesiologist
role: PRINCIPAL_INVESTIGATOR
References: