General AnesthesiaPhase 4INERTIANCT01962285
Neuronal Inertia in Propofol Anesthesia
A Phase 4 study of General Anesthesia and Propofol Pharmacodynamics, run by Universidad del Desarrollo at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia, Propofol Pharmacodynamics, Propofol Target Controlled Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChile
- Study dates
- Aug 2013to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- american society of anesthesiologists status I or II age >18 years fasted at least 8 hours BMI<30
Who cannot join
- any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol
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.
Read the 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.
- Conditions
- General Anesthesia, Propofol Pharmacodynamics, Propofol Target Controlled Infusion, Loss of Consciousness and Recovery of Consciousness, Propofol Plasma Concentration
- Being tested
- propofol targel controlled infusion
- Keywords
- neuronal inertia, loss of consciousness, propofol pharmacodynamics, Bispectral index, anesthesia, general/pharmacology
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol targel controlled infusionDrug
Also called propofol TCI
slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling
| Study group | Role | What they receive |
|---|---|---|
| propofol slow infusion | Experimental | (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 Receives: Drug: propofol targel controlled infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml)
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
Measured: 2 hours (during slow steady-state concentration propofol infusion)
Secondary outcomes (3)
Bispectral Index (BIS) al LOC and ROC
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.
Measured: 2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL
Pharmacodynamic curve for propofol.
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,
Measured: 2 hours
PROPOFOL effect site concentration during infusion
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Sepulveda, Universidad del Desarrollo
- Investigators
- pablo sepulveda, anesthesiologist, Principal investigator, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962285
- Sponsor's protocol ID
- INERTIA
- Acronym
- INERTIA
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Inertia´s Effect on Pharmacological Behavior Representation of Propofol
- ClinicalTrials.gov ID
- NCT01962285
- Acronym / sponsor ID
- INERTIA / INERTIA
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol slow infusion | Experimental | Drug: propofol targel controlled 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- american society of anesthesiologists status I or II age >18 years fasted at least 8 hours BMI<30
Key exclusion criteria (1 listed)
- any known adverse reaction to propofol administration soy or egg-protein allergy psychotropic use (illegal of medically indicated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol targel controlled infusionAlso: propofol TCIslow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling | Drug | propofol slow infusion |
Primary outcome
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
3 secondary outcomes
Bispectral Index (BIS) al LOC and ROC
Time frame: 2 hours (during slow increasing TCI (Target controlled Infusion) of PROPOFOL
Pharmacodynamic curve for propofol.
Time frame: 2 hours
PROPOFOL effect site concentration during infusion
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pablo sepulveda, anesthesiologist principal investigator
Universidad del Desarrollo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of General Anesthesia and Propofol Pharmacodynamics, run by Universidad del Desarrollo at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma-equilibrated effect site concentration of propofol at LOC and ROC (mcg/ml) (time frame: 2 hours (during slow steady-state concentration propofol infusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.