HealthyPhase 4NCT02155517
Clinical Effect of Two Pharmacokinetics Model of Propofol
A Phase 4 study testing Evaluation of propofol effect in people with Healthy, run by Tiva Group at 1 site in Venezuela.
Trial summary
Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more complete published until now. Schnider was derived from 24 healhty people, and including other covariates in addition to weight, such as age, height and lean body mass though. Schnider model should not be used in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Evaluation of propofol effect
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteVenezuela
- Study dates
- May 2014to Aug 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I
- Aged 18-60 years
- Patients with Body mass Index < 30.
Who cannot join
- Patients with Body mass Index > 30.
- Patients presenting psychiatric or neurological disorders , endocrine-metabolical problems, respiratory and cardiac diseases, or with allergies problems.
- Patients who are pregnant or breastfeeding.
- Patients treated with psychotropic drugs, including alcohol, in the 48 hours prior.
- Patients with previous history of anesthetics complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4: CLINICAL EVALUATION OF TWO PHARMACOKINETICS MODELS OF PROPOFOL IN HEALTHY PEOPLE
Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more complete published until now. Schnider was derived from 24 healhty people, and including other covariates in addition to weight, such as age, height and lean body mass though. Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese patients. The differences between both models has been founded at the initial drug distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the plasma-effect equilibration time). We believe that Cortinez model also could be used in No OBESE patients because is an allometric model, and one way to evaluate and to compare both pharmacokinetics models is studying the temporary course of the effect.
The main objective of our study is to evaluate BIS and Cardiac Output values during propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in non obese healthy volunteer.
Read the detailed description
The study was approved by the ethics committee of the Avila Clinic. After informed consent, 10 volunteers aged 18-60 años, ASA I, Body mass Index < 30 were included.
The patients fasted for 8h before the protocol and they will not receive premedication. After arrival in the operating room, and insertion of 18-gauge intravenous cannulas placed into the forearm, a Ringer's lactate solution will be initiated. Oxygen therapy at a rate of 5 litres per minute will be administered in spontaneous ventilation. In case of hypoventilation (saturation (SaO2) <95% manual ventilation with a mask at 10 l/min of O2 will be administered. All volunteer will be monitoring with EKG, Blood pressure, Pulse Oximetry, Bispectral Index and Cardiac output.
Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland ). Each volunteer will be studied twice, that means which each subject then acts as their own control.
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using Target Controlled Infusion device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using Target Controlled Infusion devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
Lost of consciousness will be evaluated by an independent observer using two different criteria: OAA/S score <2 (OAA/S2) corresponding to the absence of response to moderate prodding and loss of eyelash reflex (LOER). Time to OAA/S2 and time to LOER will be measured as well as corresponding brain and plasma concentrations of propofol. At the same time, BIS and Cardiac output values will be recording.
After 20 minutes, the infusion will be stopped. Recovery of consciousness (ROC), which will be assessed every 10s until patients wake up, and the values of Ce, BIS and Cardiac Output.
The electroencephalogram (EEG) activity will be monitored by BIS Quatro platform® electrodes and a BIS VISTA™ 1.01 monitor Vista the bispectral index (Covidien, USA). The information will be recording every 20 seconds The cardiac output will be measured using Monitor ICON ® Electrical Cardiometric ™
Arterial blood pressure, heart rate, SaO2, respiratory frequency will be measured before to start propofol infusion and then every 3 minutes until the end of trial. A decrease in systolic arterial pressure ≥30 % of the basal value will be considered as hypotension, and heart rate <45 defined bradycardia.
STATISTICAL ANALYSIS This is a prospective, descriptive and comparative study. We will use the Wilcoxon-Mann-Whitney nonparametric test applied for two independent samples
- Conditions
- Healthy
- Being tested
- Evaluation of propofol effect
- Keywords
- TCI,Schnider Model, Cortinez Model, BIS, Cardiac Output.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of propofol effectDrug
Also called Propofol Induced sedation
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
Evaluation of propofol effectDrug
Also called Propofol Induce sedation
STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Infusion | Experimental | Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland )..
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes. Receives: Drug: Evaluation of propofol effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation Levels
We will use Ramsey Sedation Scale to evaluate LOC at the beginning of the infusion and after 20 minutes we will evaluate the recovery of consciousness after the infusion is stopped.
Measured: During propofol infusion period
Secondary outcomes (2)
Bispectral index values
We will use BIS monitor (BIS Vista, Covidien). The data will be collected in excel data sheet
Measured: During a propofol infusion period
Hemodynamics values
We will measure cardiac output using Monitor ICON ® Electrical Cardiometric ™, every 3 minutes.
Measured: During propofol infusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiva Group
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Carolina Frederico, Tiva Group
- Investigators
- Carlos R Ramirez, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155517
- Sponsor's protocol ID
- 019CBCEA032013
- Status last verified
- Jul 2013
- First submitted
- 19 May 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4: CLINICAL EVALUATION OF TWO PHARMACOKINETICS MODELS OF PROPOFOL IN HEALTHY PEOPLE
- ClinicalTrials.gov ID
- NCT02155517
- Acronym / sponsor ID
- 019CBCEA032013
- Conditions
- Healthy
- Keywords
- TCI,Schnider Model, Cortinez Model, BIS, Cardiac Output.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tiva GroupUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Jun 2014 (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.
Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more complete published until now. Schnider was derived from 24 healhty people, and including other covariates in addition to weight, such as age, height and lean body mass though. Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese patients. The differences between both models has been founded at the initial drug distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the plasma-effect equilibration time). We believe that Cortinez model also could be used in No OBESE patients because is an allometric model, and one way to evaluate and to compare both pharmacokinetics models is studying the temporary course of the effect.
The main objective of our study is to evaluate BIS and Cardiac Output values during propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in non obese healthy volunteer.
Detailed description
The study was approved by the ethics committee of the Avila Clinic. After informed consent, 10 volunteers aged 18-60 años, ASA I, Body mass Index < 30 were included.
The patients fasted for 8h before the protocol and they will not receive premedication. After arrival in the operating room, and insertion of 18-gauge intravenous cannulas placed into the forearm, a Ringer's lactate solution will be initiated. Oxygen therapy at a rate of 5 litres per minute will be administered in spontaneous ventilation. In case of hypoventilation (saturation (SaO2) <95% manual ventilation with a mask at 10 l/min of O2 will be administered. All volunteer will be monitoring with EKG, Blood pressure, Pulse Oximetry, Bispectral Index and Cardiac output.
Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland ). Each volunteer will be studied twice, that means which each subject then acts as their own control.
The study will make in two stages:
STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using Target Controlled Infusion device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using Target Controlled Infusion devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
Lost of consciousness will be evaluated by an independent observer using two different criteria: OAA/S score <2 (OAA/S2) corresponding to the absence of response to moderate prodding and loss of eyelash reflex (LOER). Time to OAA/S2 and time to LOER will be measured as well as corresponding brain and plasma concentrations of propofol. At the same time, BIS and Cardiac output values will be recording.
After 20 minutes, the infusion will be stopped. Recovery of consciousness (ROC), which will be assessed every 10s until patients wake up, and the values of Ce, BIS and Cardiac Output.
The electroencephalogram (EEG) activity will be monitored by BIS Quatro platform® electrodes and a BIS VISTA™ 1.01 monitor Vista the bispectral index (Covidien, USA). The information will be recording every 20 seconds The cardiac output will be measured using Monitor ICON ® Electrical Cardiometric ™
Arterial blood pressure, heart rate, SaO2, respiratory frequency will be measured before to start propofol infusion and then every 3 minutes until the end of trial. A decrease in systolic arterial pressure ≥30 % of the basal value will be considered as hypotension, and heart rate <45 defined bradycardia.
STATISTICAL ANALYSIS This is a prospective, descriptive and comparative study. We will use the Wilcoxon-Mann-Whitney nonparametric test applied for two independent samples
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol Infusion | Experimental | Drug: Evaluation of propofol effectPropofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland ).. The study will make in two stages: STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes. STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I
- Aged 18-60 years
- Patients with Body mass Index < 30.
Key exclusion criteria (5 listed)
- Patients with Body mass Index > 30.
- Patients presenting psychiatric or neurological disorders , endocrine-metabolical problems, respiratory and cardiac diseases, or with allergies problems.
- Patients who are pregnant or breastfeeding.
- Patients treated with psychotropic drugs, including alcohol, in the 48 hours prior.
- Patients with previous history of anesthetics complications
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 |
|---|---|---|
| Evaluation of propofol effectAlso: Propofol Induced sedationThe study will make in two stages: STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes. | Drug | Propofol Infusion |
| Evaluation of propofol effectAlso: Propofol Induce sedationSTAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes. | Drug | Propofol Infusion |
Primary outcome
Sedation Levels
Time frame: During propofol infusion period
We will use Ramsey Sedation Scale to evaluate LOC at the beginning of the infusion and after 20 minutes we will evaluate the recovery of consciousness after the infusion is stopped.
2 secondary outcomes
Bispectral index values
Time frame: During a propofol infusion period
Hemodynamics values
Time frame: During propofol infusion period
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 23 Sep 2014.
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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.
Carlos R Ramirez, Dr principal investigator
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 testing Evaluation of propofol effect in people with Healthy, run by Tiva Group at 1 site in Venezuela.
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 3 inclusion and 5 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 23 Sep 2014. 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 Venezuela. 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?
Sedation Levels (time frame: During propofol infusion period). 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 23 Sep 2014.