- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962285
Neuronal Inertia in Propofol Anesthesia (INERTIA)
Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Region Metropolitana
-
Santiago, Region Metropolitana, Chile
- Clinica Alemana de Santiago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
2 hours (during slow steady-state concentration propofol infusion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL
|
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,
|
2 hours
|
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.
|
2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours
|
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.
|
2 hours (during propofol infusion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: pablo sepulveda, anesthesiologist, Universidad del Desarrollo
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INERTIA
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