Propofol OverdosePhase 4NCT04345926
Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns
A Phase 4 study testing Propofol and Electroencephalogram recording in people with Propofol Overdose and EEG, run by University of Chile at 2 sites in Chile.
Trial summary
In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Propofol Overdose, EEG
- What is being tested?
- Propofol and Electroencephalogram recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChile
- Study dates
- 16 Aug 2018to 26 Feb 2020
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- Low-risk surgery
Who cannot join
- BMI > 35 kg/m2
- Benzodiazepines use
- Epilepsy
- Psychiatric disorder
- Kidney disease
- Liver disease
- Brain damage
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
About this study
Official title: Determination of Dose-response Curves Between Propofol Concentration and Intraoperative Electroencephalographic Patterns Until Burst Suppression
In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.
Read the detailed description
The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.
- Conditions
- Propofol Overdose, EEG
- Being tested
- Propofol, Electroencephalogram recording
- Keywords
- Propofol, General anesthesia, EEG, Burst suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Dosage increase
Stepped propofol concentration after 20 min of LOS
Electroencephalogram recordingDevice
Acquisition of EEG activity
| Study group | Role | What they receive |
|---|---|---|
| Dose-response | Experimental | 1. - Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time).
2. - Patients will be intubated and remifentanil will be decreased to 4 ng/mL.
3. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time).
4. - Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time).
EEG activity will be acquired using a SedLine® monitor during the complete protocol. Receives: Drug: Propofol; Device: Electroencephalogram recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the alpha power of EEG Spectrogram
% of change
Measured: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Secondary outcomes (3)
Change in the delta power of EEG Spectrogram
% of change
Measured: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the coherence
% of change
Measured: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the propofol concentration
concentration in mcg/mL
Measured: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start16 Aug 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol OverdoseStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonello Penna, University of Chile
- Investigators
- Jose I Egaña, MD/PhD, Principal investigator, University of ChileFelipe Maldonado, MD, Principal investigator, University of ChileRodrigo Gutierrez, MD/PhD, Principal investigator, University of ChileAntonello Penna, MD/PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345926
- Sponsor's protocol ID
- OAIC 938/18
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dose-response Curves Between Propofol Concentration and Intraoperative Electroencephalographic Patterns Until Burst Suppression
- ClinicalTrials.gov ID
- NCT04345926
- Acronym / sponsor ID
- OAIC 938/18
- Conditions
- Propofol Overdose, EEG
- Keywords
- Propofol, General anesthesia, EEG, Burst suppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 15 Apr 2020 (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.
In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.
Detailed description
The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-response | Experimental | Drug: Propofol, Device: Electroencephalogram recording1. - Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time). 2. - Patients will be intubated and remifentanil will be decreased to 4 ng/mL. 3. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time). 4. - Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time). EEG activity will be acquired using a SedLine® monitor during the complete protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- Low-risk surgery
Key exclusion criteria (7 listed)
- BMI > 35 kg/m2
- Benzodiazepines use
- Epilepsy
- Psychiatric disorder
- Kidney disease
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 |
|---|---|---|
| PropofolAlso: Dosage increaseStepped propofol concentration after 20 min of LOS | Drug | Dose-response |
| Electroencephalogram recordingAcquisition of EEG activity | Device | Dose-response |
Primary outcome
Change in the alpha power of EEG Spectrogram
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
% of change
3 secondary outcomes
Change in the delta power of EEG Spectrogram
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the coherence
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Change in the propofol concentration
Time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)
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 28 Apr 2021.
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 I Egaña, MD/PhD principal investigator
University of Chile
Felipe Maldonado, MD principal investigator
University of Chile
Rodrigo Gutierrez, MD/PhD principal investigator
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Electroencephalogram recording in people with Propofol Overdose and EEG, run by University of Chile at 2 sites 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 2 inclusion and 7 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in the alpha power of EEG Spectrogram (time frame: Change between baseline time (0 minutes) and burst suppression time (35 minutes)). 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 28 Apr 2021.