Neuronal Inertia in Propofol Anesthesia (INERTIA)
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|ClinicalTrials.gov Identifier: NCT01962285|
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia Propofol Pharmacodynamics Propofol Target Controlled Infusion Loss of Consciousness and Recovery of Consciousness Propofol Plasma Concentration||Drug: propofol targel controlled infusion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Experimental: 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
Drug: propofol targel controlled infusion
slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling
Other Name: propofol TCI
- plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml) [ Time Frame: 2 hours (during slow steady-state concentration propofol infusion) ]
determination of plasma concentration of PROPOFOL at the time of Loss of Consciousness and the time of recovery of consciousness during the 7-minute step infusion.
Provided it is a slow increasing infusion we assume a pseudo-equilibrium state between plasma and effect site.
the existence of a difference between these two values will support the hypothesis of neuronal inertia
- Bispectral Index (BIS) al LOC and ROC [ Time Frame: 2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL ]
we measured the BISPECTRAL INDEX all through the protocol: from previous to start the infusion until 7 minutes after recovery of consciousness. values of BIS at LOC and ROC will be compared.
a potential difference found between those two values supports the theory thas LOC and ROC reflects different neuronal processes Other clinically relevant endpoints (loss of palpebral reflex, onset of amnesia) will be registered in order to build the pharmacodynamic loop.
- Pharmacodynamic curve for propofol. [ Time Frame: 2 hours ]plasma concentration of PROPOFOL (mcg/ml) at other clinically relevant endpoints (amnesia onset, loss of palpebral reflex, etc...) will be determined in order to build a pharmacodynamic curve,
- PROPOFOL effect site concentration during infusion [ Time Frame: 2 hours ]plasma concentration of PROPOFOL (mcg/ml) from venous blood samples will be determinated every 7 minutes, that means at the end of each TCI step. assuming the 7-minute step gave enough time to reach a pseudo-equilibrium state, we consider the results comparable to effect site concentration.
- performance of Schnider´s pharmacokinetic parameters in a slow infusion [ Time Frame: 2 hours ]to compare plasma (and effect site) Propofol concentration predicted by the model with measured values thus evaluating model´s performance. Median performance error (MDPE) and median absolute performance error (MDAPE), divergence and other often reported parameters will be determinated.
- Electroencephalographic behavior at LOC and ROC during Propofol infusion [ Time Frame: 2 hours (during propofol infusion) ]spectral analisis of 32-channel EEG during infusion. a specified time-frame around those two events (i.e.: 14 minutes) will be reconstructed in images and analyzed. cortical areas with enhanced activity and how do this activity changes during loss of consciousness and the recovery of it will be evaluated with a mathematical model in order two determine wether those events correspond with two different processes instead of a bidirectional single one.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962285
|Clinica Alemana de Santiago|
|Santiago, Region Metropolitana, Chile|
|Principal Investigator:||pablo sepulveda, anesthesiologist||Universidad del Desarrollo|