Anesthesia, GeneralPLENCT03299621
Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia
A study testing PLE (Phase Lag Entropy) and Muscle Relaxant in people with Anesthesia, General, run by Korea University Anam Hospital at 2 sites in South Korea.
Trial summary
The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- PLE (Phase Lag Entropy) and Muscle Relaxant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Nov 2017to 31 Aug 2018
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)
Who cannot join
- Patients with difficulty airway
- Patients with cardiovascular disease
- Patients with cerebrovascular disease
- Patients with respiratory disease
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, Inchon-ro 8-gil 73, 02841
Hye-Won Shin, Ph.D., 821092735025, drhwshin@naver.com
- Recruiting
Korea University Anam Hospital
Seoul
Hye Won Shin, M.D., PhD.
About this study
Official title: Anesthetic Depth Using PLE (Phase Lag Entropy)
The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia
Read the detailed description
The devices using EEG are commonly used for measuring the depth of consciousness during anesthesia. However, the existing devices are largely dependent on the biphasic analysis of 1-channel EEG signals, and thus do not provide proper information for anesthetic depth.
Recent study reported that the complexity or diversity of communication between the brain regions is related to the level of consciousness. In particular, during anesthesia, the phase synchronization (phase shift) between EEG signals at the front of the brain increases, indicating a reduction in communication diversity and a close relationship with loss of consciousness. Therefore, to predict the depth of sleep, a technique for precisely quantifying the complexity of inter-domain communication in the frontal brain is needed. Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be present in a patient who is sleeping or anesthetized.
The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used to measure the depth of anesthesia.
- Conditions
- Anesthesia, General
- Being tested
- PLE (Phase Lag Entropy), Muscle Relaxant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLE (Phase Lag Entropy)Device
Also called PLEM™ (Inbody co., ltd)
Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.
Muscle RelaxantDrug
Also called Muscle relaxant (rocuronium)
Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| PLE (Phase Lag Entropy) monitoring | Experimental | Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia. Receives: Device: PLE (Phase Lag Entropy) |
| Muscle relaxant injection | Experimental | Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant. Receives: Drug: Muscle Relaxant |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLE (Phase Lag Entropy) value before and after intubation
Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
Measured: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Secondary outcomes (4)
PLE value before and after the injection of muscle relaxant
Investigators measure the PLE value before the injection of muscle relaxant, at 3 min after the injection of muscle relaxant, and immediately after intubation.
Measured: at 3 min after the injection of muscle relaxant, immediately after intubation
PLE value and BIS value at that time of induction and awakening
Investigators measure the PLE value and BIS value at the time point of no-response to verbal command during induction ('modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2], at the time point of response to verbal command during awakening [modified OAA/S scale = 3].
Measured: at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).
Bispectral index (BIS) value before and after intubation
Investigators measure the Bispectral index (BIS) value at time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
Measured: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation
Investigators calculate band power from the data file at the time points that propofol target effect site concentration reach 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
Measured: at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start13 Nov 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
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, GeneralStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-Won Shin, Korea University Anam Hospital
- Investigators
- Hye-Won Shin, Ph.D., Principal investigator, Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299621
- Sponsor's protocol ID
- MD17014
- Acronym
- PLE
- Status last verified
- Nov 2017
- First submitted
- 25 Aug 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin HW, Kim HJ, Jang YK, You HS, Huh H, Choi YJ, Choi SU, Hong JS. Monitoring of anesthetic depth and EEG band power using phase lag entropy during propofol anesthesia. BMC Anesthesiol. 2020 Feb 26;20(1):49. doi: 10.1186/s12871-020-00964-5.
PubMed 32102676
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Depth Using PLE (Phase Lag Entropy)
- ClinicalTrials.gov ID
- NCT03299621
- Acronym / sponsor ID
- PLE / MD17014
- Conditions
- Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 3 Oct 2017 (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 evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia
Detailed description
The devices using EEG are commonly used for measuring the depth of consciousness during anesthesia. However, the existing devices are largely dependent on the biphasic analysis of 1-channel EEG signals, and thus do not provide proper information for anesthetic depth.
Recent study reported that the complexity or diversity of communication between the brain regions is related to the level of consciousness. In particular, during anesthesia, the phase synchronization (phase shift) between EEG signals at the front of the brain increases, indicating a reduction in communication diversity and a close relationship with loss of consciousness. Therefore, to predict the depth of sleep, a technique for precisely quantifying the complexity of inter-domain communication in the frontal brain is needed. Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be present in a patient who is sleeping or anesthetized.
The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used to measure the depth of anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLE (Phase Lag Entropy) monitoring | Experimental | Device: PLE (Phase Lag Entropy)Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia. |
| Muscle relaxant injection | Experimental | Drug: Muscle RelaxantInvestigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)
Key exclusion criteria (4 listed)
- Patients with difficulty airway
- Patients with cardiovascular disease
- Patients with cerebrovascular disease
- Patients with respiratory 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 |
|---|---|---|
| PLE (Phase Lag Entropy)Also: PLEM™ (Inbody co., ltd)Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia. | Device | PLE (Phase Lag Entropy) monitoring |
| Muscle RelaxantAlso: Muscle relaxant (rocuronium)Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation. | Drug | Muscle relaxant injection |
Primary outcome
PLE (Phase Lag Entropy) value before and after intubation
Time frame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
4 secondary outcomes
PLE value before and after the injection of muscle relaxant
Time frame: at 3 min after the injection of muscle relaxant, immediately after intubation
PLE value and BIS value at that time of induction and awakening
Time frame: at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).
Bispectral index (BIS) value before and after intubation
Time frame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation
Time frame: at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 32102676Shin HW, Kim HJ, Jang YK, You HS, Huh H, Choi YJ, Choi SU, Hong JS. Monitoring of anesthetic depth and EEG band power using phase lag entropy during propofol anesthesia. BMC Anesthesiol. 2020 Feb 26;20(1):49. doi: 10.1186/s12871-020-00964-5.
Related trials for Anesthesia, General
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Hye-Won Shin, Ph.D. principal investigator
Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLE (Phase Lag Entropy) and Muscle Relaxant in people with Anesthesia, General, run by Korea University Anam Hospital at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jung Kim, M.D. (821033859168, k87876655@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLE (Phase Lag Entropy) value before and after intubation (time frame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation). 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 NCT03299621, 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 14 Nov 2017.