Anesthesia for Elective Surgery Patientsfast or slow ENCT07237477
Reevaluation Prediction of the Effect Site Propofol Eleveld Model Using Slow and Fast Induction
An observational study of Anesthesia for Elective Surgery Patients and Anesthesia Brain Monitor, run by Pablo O. Sepulveda at 1 site in Chile.
Trial summary
Patients ASA1-2, 18 to 70 years old, scheduled for elective surgery with personal conset to participate, will be randomised into two groups using different induction mode. TCI effect site mode induction or TCI plasma mode induction both using the Elevelt PKPD propofol model. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia for Elective Surgery Patients, Anesthesia Brain Monitor, Pharmacodynamics
- What is being tested?
- Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteChile
- Study dates
- 15 Jan 2025to 15 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour
Inclusion Criteria: patients ASA 1-2 scheduled for elective surgery, Exclusion Criteria: patients with psychiatric disorders, allergic to propofol, not giving their consent to participate
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Site Effect Model Prediction and BIS Predicted by Eleveld for Propofol in Slow and Rapid Inductions
Patients ASA1-2, 18 to 70 years old, scheduled for elective surgery with personal conset to participate, will be randomised into two groups using different induction mode. TCI effect site mode induction or TCI plasma mode induction both using the Elevelt PKPD propofol model. Standard monitoring (EKG, SaO2, PCo2et, NIAP), and Conox/ and or BIS EEG monitor to evaluate the prediction.
The model's prediction will be compared with values provided by the Conox/BIS index for both groups and between them. The study will be conducted during the 20 minutes after Loss of responsiveness.
Read the detailed description
Patients aged 18 to 70 years will be included. Patients allergic to propofol are excluded. Eleveld's PKPD model for propofol includes covariates for adjustment in administration with target-controlled infusion pumps. Induction to the site of effect will be performed using EC60 for each age, while slow induction will use the target plasma modality, starting at a target of 3 ug/ml and increasing by 0.5 ug/ml every 3 minutes until loss of consciousness. This is defined as the loss of response to voice and shoulder tap. The 20 minutes following loss of consciousness will be evaluated.
Biometric and gender characteristics of both groups, concomitant pathologies, and surgical times will be compared.
The temporal evolution of the propofol effect site predicted by the Eleveld model will be compared between the two types of induction using EEG (CONOX or BIS). To obtain the EEG index prediction by Eleveld it will be use the Tiva trainer software 2.0, simulating the evolution of the kinetics and effect site calculated by Eleveld in the infudion TCI pumps.
It is estimated that 20 patients per group are required to find a 20% difference in predicted versus actual EEG index with 90% power.
Statistical methods:
- Data analysis tool: Stata 10 software
- Statistics
- Summary: Mean (central tendency) and standard deviation (dispersion)
- Association: Student's t-test for continuous quantitative variables and Fisher's exact test for dichotomous variables.
- Being tested
- Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction
- Keywords
- Propofol, Eleveld model, induction flow, CONOX,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) inductionDrug
Using TCI technology and EEG monitoring (CONOX) we will induce loss of responsiveness using the fast induction (Group 1) or slow induction (Group 2) and compare the prediction of the effect site model (PD) in each type of induction.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction | Patients ASA 1-2, 18 to 70 years, will be induced using propofol TCI in effect site mode EC60 of the Eleveld PKPD model and compared with the EEG CONOX behavior, If lost of responsiveness (LOR) was not reached, we climb up 0,5 ug/ml every 3 min. At LOR calculated effect site concentration will be used as reference to mantain anesthesia level. Receives: Drug: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction | |
| Group 2: the prediction of the Eleveld propofol model in TCI plasma mode | Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour. Induced with TCI plasma mode using the Eleveld PKPD model. The infusion will begin using a target plasma of 3 ug/ml, and scale every 3 minutes in 0,5 ug/ml until Loss of responsiveness (LOR). At LOR the calculated effect site concentration will be used as reference to mantain anesthesia level. EEG (CONOX or BIS) will be used to evaluate the prediction of the model. Receives: Drug: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of the efect site propofol Eleveld model
The comparison betwen predicted and actual CONOX/BIS index will be made in two scenario: TCI effect site mode induction versus TCI plasma mode induction
Measured: The data will be retrieved directly from the infusion pumps and EEGs up to 20 minutes after the loss of clinical consciousness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Jan 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia for Elective Surgery PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pablo O. Sepulveda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo O. Sepulveda, Universidad del Desarrollo
- Investigators
- José Gonzalez Gonzalez, PHD, Study director, Departamento de Investigación Hospital osorno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237477
- Sponsor's protocol ID
- Hospital Base San José Osoro
- Acronym
- fast or slow E
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Part of the analysis will be conducted by Matthias Kreuzer Techische Universität München
Publications
Coetzee E, Coetzee JF, Haasbroek M. Predictive pharmacodynamic performance of the Eleveld pharmacokinetic-pharmacodynamic model for propofol: comparison of predicted and measured bispectral index. Br J Anaesth. 2024 Oct;133(4):785-792. doi: 10.1016/j.bja.2024.06.041. Epub 2024 Aug 23.
PubMed 39179443
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Site Effect Model Prediction and BIS Predicted by Eleveld for Propofol in Slow and Rapid Inductions
- ClinicalTrials.gov ID
- NCT07237477
- Acronym / sponsor ID
- fast or slow E / Hospital Base San José Osoro
- Keywords
- Propofol, Eleveld model, induction flow, CONOX,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pablo O. SepulvedaUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- 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.
Patients ASA1-2, 18 to 70 years old, scheduled for elective surgery with personal conset to participate, will be randomised into two groups using different induction mode. TCI effect site mode induction or TCI plasma mode induction both using the Elevelt PKPD propofol model. Standard monitoring (EKG, SaO2, PCo2et, NIAP), and Conox/ and or BIS EEG monitor to evaluate the prediction.
The model's prediction will be compared with values provided by the Conox/BIS index for both groups and between them. The study will be conducted during the 20 minutes after Loss of responsiveness.
Detailed description
Patients aged 18 to 70 years will be included. Patients allergic to propofol are excluded. Eleveld's PKPD model for propofol includes covariates for adjustment in administration with target-controlled infusion pumps. Induction to the site of effect will be performed using EC60 for each age, while slow induction will use the target plasma modality, starting at a target of 3 ug/ml and increasing by 0.5 ug/ml every 3 minutes until loss of consciousness. This is defined as the loss of response to voice and shoulder tap. The 20 minutes following loss of consciousness will be evaluated.
Biometric and gender characteristics of both groups, concomitant pathologies, and surgical times will be compared.
The temporal evolution of the propofol effect site predicted by the Eleveld model will be compared between the two types of induction using EEG (CONOX or BIS). To obtain the EEG index prediction by Eleveld it will be use the Tiva trainer software 2.0, simulating the evolution of the kinetics and effect site calculated by Eleveld in the infudion TCI pumps.
It is estimated that 20 patients per group are required to find a 20% difference in predicted versus actual EEG index with 90% power.
Statistical methods:
- Data analysis tool: Stata 10 software
- Statistics
- Summary: Mean (central tendency) and standard deviation (dispersion)
- Association: Student's t-test for continuous quantitative variables and Fisher's exact test for dichotomous variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction | – | Drug: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) inductionPatients ASA 1-2, 18 to 70 years, will be induced using propofol TCI in effect site mode EC60 of the Eleveld PKPD model and compared with the EEG CONOX behavior, If lost of responsiveness (LOR) was not reached, we climb up 0,5 ug/ml every 3 min. At LOR calculated effect site concentration will be used as reference to mantain anesthesia level. |
| Group 2: the prediction of the Eleveld propofol model in TCI plasma mode | – | Drug: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) inductionPatients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour. Induced with TCI plasma mode using the Eleveld PKPD model. The infusion will begin using a target plasma of 3 ug/ml, and scale every 3 minutes in 0,5 ug/ml until Loss of responsiveness (LOR). At LOR the calculated effect site concentration will be used as reference to mantain anesthesia level. EEG (CONOX or BIS) will be used to evaluate the prediction of the model. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour
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 the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) inductionUsing TCI technology and EEG monitoring (CONOX) we will induce loss of responsiveness using the fast induction (Group 1) or slow induction (Group 2) and compare the prediction of the effect site model (PD) in each type of induction. | Drug | Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction, Group 2: the prediction of the Eleveld propofol model in TCI plasma mode |
Primary outcome
Prediction of the efect site propofol Eleveld model
Time frame: The data will be retrieved directly from the infusion pumps and EEGs up to 20 minutes after the loss of clinical consciousness.
The comparison betwen predicted and actual CONOX/BIS index will be made in two scenario: TCI effect site mode induction versus TCI plasma mode induction
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 19 Nov 2025.
- Results publication: PubMed 39179443Coetzee E, Coetzee JF, Haasbroek M. Predictive pharmacodynamic performance of the Eleveld pharmacokinetic-pharmacodynamic model for propofol: comparison of predicted and measured bispectral index. Br J Anaesth. 2024 Oct;133(4):785-792. doi: 10.1016/j.bja.2024.06.041. Epub 2024 Aug 23.
- this study discuss about the problem of the Eleveld effect site prediction using diferent induction flowsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Part of the analysis will be conducted by Matthias Kreuzer Techische Universität München
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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.
José Gonzalez Gonzalez, PHD study director
Departamento de Investigación Hospital osorno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia for Elective Surgery Patients and Anesthesia Brain Monitor, run by Pablo O. Sepulveda 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?
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 19 Nov 2025. 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.
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?
Prediction of the efect site propofol Eleveld model (time frame: The data will be retrieved directly from the infusion pumps and EEGs up to 20 minutes after the loss of clinical consciousness.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237477, which also lists 1 linked publication.
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 19 Nov 2025.