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Neuronal Inertia in Propofol Anesthesia

NCT ID: NCT01962285

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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General Anesthesia Propofol Pharmacodynamics Propofol Target Controlled Infusion Loss of Consciousness and Recovery of Consciousness Propofol Plasma Concentration

Keywords

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neuronal inertia loss of consciousness propofol pharmacodynamics Bispectral index anesthesia, general/pharmacology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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propofol slow infusion

(healthy volunteers, non invasive monitoring and O2 supply via nasal cannula) Target controlled infusion of propofol using Schnider´s pharmacokinetic parameters in a slow, stepped fashion. beginning at Cp 0.5 mcg/ml and increasing in 0.5 mcg/ml every 7 minutes until LOC occurred, then a prolonged step of 14 minutes (2 samples), increase 2 steps further and then decrease in 0.5 mcg/ml steps until ROC and a 7 minute registry after ROC.

Blood sampling for propofol plasma level every 7 minutes (at the end of each step, allowing for pseudo-equilibrium condition.

32 channel-EEg and BIS continuous monitoring

Group Type EXPERIMENTAL

propofol targel controlled infusion

Intervention Type DRUG

slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling

Interventions

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propofol targel controlled infusion

slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling

Intervention Type DRUG

Other Intervention Names

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propofol TCI

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad del Desarrollo

OTHER

Sponsor Role lead

Responsible Party

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Pablo Sepulveda

Médico Cirujano

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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pablo sepulveda, anesthesiologist

Role: PRINCIPAL_INVESTIGATOR

Universidad del Desarrollo

Locations

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Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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INERTIA

Identifier Type: -

Identifier Source: org_study_id