Propofol Overdose of Undetermined IntentNCT04520503
Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
An observational study of Propofol Overdose of Undetermined Intent, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an… Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Propofol Overdose of Undetermined Intent
- What is being tested?
- Propofol and EEG monitoring
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2020to 28 Feb 2022
- 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia
Who may be able to join
- Adult patients undergoing general anesthesia
Who cannot join
- Patients undergoing cardiac or brain surgery
- Patients with neurological deficit or impaired communication (Glasgow Coma Scale < 15)
- Unstable vital sign (cardiogenic, hemorrhagic, septic shock)
- Patients with eclampsia
- Patients who administered preoperative anxiolytics
- Patients who do not require intubation
- Patients who are considered unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.
- Conditions
- Propofol Overdose of Undetermined Intent
- Being tested
- Propofol, EEG monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
The dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients.
EEG monitoringDevice
The processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution.
| Study group | Role | What they receive |
|---|---|---|
| Pre EEG group | This cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained Receives: Drug: Propofol; Device: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
Measured: During the induction of anesthesia (up to 15 min)
Processed EEG index (PSI; patient state index)
Processed EEG index (PSI; patient state index)
Measured: During the induction of anesthesia (up to 15 min)
Mean frequency and 95% spectral edge frequency (Hz)
Mean frequency and 95% spectral edge frequency (Hz)
Measured: During the induction of anesthesia (up to 15 min)
Burst suppression ratio (%)
Burst suppression ratio (%)
Measured: During the induction of anesthesia (up to 15 min)
Secondary outcomes (7)
The effect-site concentrations of propofol at loss of consciousness (μg/ml)
The effect-site concentrations of propofol at loss of consciousness (μg/ml)
Measured: During the induction of anesthesia (up to 15 min)
The dose of propofol required for loss of consciousness (mg)
The dose of propofol required for loss of consciousness (mg)
Measured: During the induction of anesthesia (up to 15 min)
Total amount of propofol used (mg)
Total amount of propofol used (mg)
Measured: During the induction of anesthesia (up to 15 min)
Time to loss of consciousness (second)
Time to loss of consciousness (second) after the start of induction
Measured: During the induction of anesthesia (up to 15 min)
Vital sign - blood pressure
Check blood pressure (mmHg)
Measured: During the induction of anesthesia (up to 15 min)
Vital sign - heart rate
Check heart rate (beats per minute)
Measured: During the induction of anesthesia (up to 15 min)
Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)
Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)
Measured: During the induction of anesthesia (up to 15 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start9 Sep 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Overdose of Undetermined IntentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520503
- Sponsor's protocol ID
- pre-induction EEG
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2020
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
- ClinicalTrials.gov ID
- NCT04520503
- Acronym / sponsor ID
- pre-induction EEG
- Conditions
- Propofol Overdose of Undetermined Intent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 Aug 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.
The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre EEG group | – | Drug: Propofol, Device: EEG monitoringThis cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia
Key inclusion criteria (1 listed)
- Adult patients undergoing general anesthesia
Key exclusion criteria (7 listed)
- Patients undergoing cardiac or brain surgery
- Patients with neurological deficit or impaired communication (Glasgow Coma Scale < 15)
- Unstable vital sign (cardiogenic, hemorrhagic, septic shock)
- Patients with eclampsia
- Patients who administered preoperative anxiolytics
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 |
|---|---|---|
| PropofolThe dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients. | Drug | Pre EEG group |
| EEG monitoringThe processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution. | Device | Pre EEG group |
Primary outcome
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
Time frame: During the induction of anesthesia (up to 15 min)
Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
Processed EEG index (PSI; patient state index)
Time frame: During the induction of anesthesia (up to 15 min)
Processed EEG index (PSI; patient state index)
Mean frequency and 95% spectral edge frequency (Hz)
Time frame: During the induction of anesthesia (up to 15 min)
Mean frequency and 95% spectral edge frequency (Hz)
Burst suppression ratio (%)
Time frame: During the induction of anesthesia (up to 15 min)
Burst suppression ratio (%)
7 secondary outcomes
The effect-site concentrations of propofol at loss of consciousness (μg/ml)
Time frame: During the induction of anesthesia (up to 15 min)
The dose of propofol required for loss of consciousness (mg)
Time frame: During the induction of anesthesia (up to 15 min)
Total amount of propofol used (mg)
Time frame: During the induction of anesthesia (up to 15 min)
Time to loss of consciousness (second)
Time frame: During the induction of anesthesia (up to 15 min)
Vital sign - blood pressure
Time frame: During the induction of anesthesia (up to 15 min)
Vital sign - heart rate
Time frame: During the induction of anesthesia (up to 15 min)
Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)
Time frame: During the induction of anesthesia (up to 15 min)
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 16 Oct 2023.
- Individual participant dataSharing planned: Undecided
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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
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 Propofol Overdose of Undetermined Intent, run by Seoul National University Hospital at 1 site in South Korea.
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 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 16 Oct 2023. 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 South Korea. 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?
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz) (time frame: During the induction of anesthesia (up to 15 min)). The study lists 4 primary outcomes in all. 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 16 Oct 2023.