Hypnotic EffectNCT02706665
Monitoring of Hypnosis State During General Anesthesia With Propofol by Patient State Index From SEDLine®
An observational study of Hypnotic Effect, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnotic Effect
- What is being tested?
- SEDline monitor
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients undergoing a surgery procedure with general anesthesia.
Who may be able to join
- American Society of Anesthesiologists classification of I, II, or III
- Patient signed an informed consent
Who cannot join
- Patients with prior neurological disease, epilepsy or stroke.
- Patients who are receiving drug therapy that may alter processed EEG monitoring and decrease the PSI accuracy.
- American Society of Anesthesiologists classification IV or higher
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
Read the detailed description
Introduction:
There is a large intra-and interindividual variability in the effect of propofol. To deal with this problem, a real-time monitoring and therefore a more accurate titration of anesthetic agents is proposed. Brain function monitors based on a processed analysis of EEG (Electroencephalogram) can help to control pharmacodynamic effects of hypnotic agents. PSI values provide a measurement of the hypnotic effect of propofol. It will be observed an inverse correlation between the propofol infusion rate and the PSI value.
Objectives:
To design a computer program to record simultaneously the propofol infusion rate, PSI and Electromyogram (EMG).
To study the correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
To obtain a mathematical model of the system from data recorded with different identification techniques.
Methods:
A group of patients scheduled for surgery under a standard total intravenous anesthesia (TIVA) with propofol and remifentanil will be recruited. The hypnotic effect of propofol will be monitored with the PSI from a SEDline monitor continuously. All anesthetic doses and their changes fall within conventional dosing.
The procedure for recording data and obtaining the pharmacokinetics/pharmacodynamics (PK / PD) model will be connecting a SEDLine® monitor to a laptop with an original program developed by members of our team. The program automatically stores the infusion rate of propofol (mg/kg/h) and the simultaneous values of PSI and frontal EMG. Graphics and data collected will be explored with various systems of techniques for pattern recognition in order to get the best fit to define a mathematical model of the dose of propofol and PSI values. A subsequent computer analysis with MATLAB® will estimate the correlation between the infusion of propofol infusion rate and PSI values.
- Conditions
- Hypnotic Effect
- Being tested
- SEDline monitor
- Keywords
- Anesthetics, Propofol, Electroencephalography, SEDline monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEDline monitorOther
The SEDline monitor gives us the Patient State Index (PSI), a dimensionless number within a range of 0 to100.
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index
The values from the SEDLine ® monitor inversely correlate with the rate of infusion of propofol. Changes in that velocity correspond to changes in the effect site (CNS) and are related to the PSI values displayed in the monitor.
Measured: During general anaesthesia in the operating room for a scheduled surgery.
Secondary outcomes (1)
Time from discontinuation of intravenous agents to open eyes to order
It will be measured with a chronometer
Measured: In the operation room at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypnotic EffectStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Sponsor
- Investigators
- Jose Antonio Reboso Morales, MD, PhD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706665
- Sponsor's protocol ID
- 2013_10
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling Pharmacokinetic/Pharmacodynamic of Propofol Based on PSI Values From the SEDline®
- ClinicalTrials.gov ID
- NCT02706665
- Acronym / sponsor ID
- 2013_10
- Conditions
- Hypnotic Effect
- Keywords
- Anesthetics, Propofol, Electroencephalography, SEDline monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 11 Mar 2016 (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.
The purpose of this study is the evaluation of possible relationships and correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
Detailed description
Introduction:
There is a large intra-and interindividual variability in the effect of propofol. To deal with this problem, a real-time monitoring and therefore a more accurate titration of anesthetic agents is proposed. Brain function monitors based on a processed analysis of EEG (Electroencephalogram) can help to control pharmacodynamic effects of hypnotic agents. PSI values provide a measurement of the hypnotic effect of propofol. It will be observed an inverse correlation between the propofol infusion rate and the PSI value.
Objectives:
To design a computer program to record simultaneously the propofol infusion rate, PSI and Electromyogram (EMG).
To study the correlation between PSI values obtained from the SEDLine® monitor and the infusion rate of propofol during general anesthesia.
To obtain a mathematical model of the system from data recorded with different identification techniques.
Methods:
A group of patients scheduled for surgery under a standard total intravenous anesthesia (TIVA) with propofol and remifentanil will be recruited. The hypnotic effect of propofol will be monitored with the PSI from a SEDline monitor continuously. All anesthetic doses and their changes fall within conventional dosing.
The procedure for recording data and obtaining the pharmacokinetics/pharmacodynamics (PK / PD) model will be connecting a SEDLine® monitor to a laptop with an original program developed by members of our team. The program automatically stores the infusion rate of propofol (mg/kg/h) and the simultaneous values of PSI and frontal EMG. Graphics and data collected will be explored with various systems of techniques for pattern recognition in order to get the best fit to define a mathematical model of the dose of propofol and PSI values. A subsequent computer analysis with MATLAB® will estimate the correlation between the infusion of propofol infusion rate and PSI values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients undergoing a surgery procedure with general anesthesia.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists classification of I, II, or III
- Patient signed an informed consent
Key exclusion criteria (3 listed)
- Patients with prior neurological disease, epilepsy or stroke.
- Patients who are receiving drug therapy that may alter processed EEG monitoring and decrease the PSI accuracy.
- American Society of Anesthesiologists classification IV or higher
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 |
|---|---|---|
| SEDline monitorThe SEDline monitor gives us the Patient State Index (PSI), a dimensionless number within a range of 0 to100. | Other | – |
Primary outcome
EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index
Time frame: During general anaesthesia in the operating room for a scheduled surgery.
The values from the SEDLine ® monitor inversely correlate with the rate of infusion of propofol. Changes in that velocity correspond to changes in the effect site (CNS) and are related to the PSI values displayed in the monitor.
1 secondary outcome
Time from discontinuation of intravenous agents to open eyes to order
Time frame: In the operation room at the end of surgery
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 17 Oct 2019.
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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.
Jose Antonio Reboso Morales, MD, PhD principal investigator
Hospital Universitario de Canarias
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 Hypnotic Effect, run by Hospital Universitario de Canarias at 1 site in Spain.
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 2 inclusion and 3 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 17 Oct 2019. 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 Spain. 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?
EEG processed will be measured by non invasive adhesive electrodes on the skin of the forehead's patient. A disposable sensor connected with a SEDLine provides de PSI index (time frame: During general anaesthesia in the operating room for a scheduled surgery.). 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 17 Oct 2019.