General AnesthesiaNCT03424720
Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator
A study testing PLE and BIS in people with General Anesthesia, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- PLE and BIS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2017to 31 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2
Who cannot join
- Patient who has been taken anticonvulsant agents, sedatives, and hypnotics
- Patient who has central nerve system disease, neurological disorder
- Patient with hypersensitivity to anesthetics
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Medical Center
Anyang-si, Gyeonggi-do
Kyung Mi Kim, Ph.D., 82313803945
Kyung Mi Kim, Ph.D.
About this study
Official title: Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring
The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator
Read the detailed description
- To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.
- In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.
- Conditions
- General Anesthesia
- Being tested
- PLE and BIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLE and BISDevice
Investigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Comparison of PLE and BIS | Experimental | Investigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring Receives: Device: PLE and BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLE value during induction and emergence of general anesthesia
Investigators measure the PLE value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia.
The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).
Measured: Through study completion, an average of fifteen months
Secondary outcomes (3)
BIS value during induction and emergence of general anesthesia
Investigators measure the BIS value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia.
The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).
Measured: Through study completion, an average of fifteen months
PLE value during facial nerve integrity monitoring
Investigators measure the PLE value at the time points of facial nerve integrity monitoring.
The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).
Measured: Through study completion, an average of fifteen months
BIS value during facial nerve integrity monitoring
Investigators measure the BIS value at the time points of facial nerve integrity monitoring.
The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).
Measured: Through study completion, an average of fifteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start2 Aug 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Mi Kim, Hallym University Medical Center
- Investigators
- Kyung Mi Kim, Ph.D., Principal investigator, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424720
- Sponsor's protocol ID
- 3-2017-10047988
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2018
- Last updated
- 7 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring
- ClinicalTrials.gov ID
- NCT03424720
- Acronym / sponsor ID
- 3-2017-10047988
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 7 Feb 2018 (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 aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator
Detailed description
- To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.
- In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of PLE and BIS | Experimental | Device: PLE and BISInvestigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2
Key exclusion criteria (3 listed)
- Patient who has been taken anticonvulsant agents, sedatives, and hypnotics
- Patient who has central nerve system disease, neurological disorder
- Patient with hypersensitivity to anesthetics
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 and BISInvestigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics | Device | Comparison of PLE and BIS |
Primary outcome
PLE value during induction and emergence of general anesthesia
Time frame: Through study completion, an average of fifteen months
Investigators measure the PLE value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia. The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).
3 secondary outcomes
BIS value during induction and emergence of general anesthesia
Time frame: Through study completion, an average of fifteen months
PLE value during facial nerve integrity monitoring
Time frame: Through study completion, an average of fifteen months
BIS value during facial nerve integrity monitoring
Time frame: Through study completion, an average of fifteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Kyung Mi Kim, Ph.D. principal investigator
Department of Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLE and BIS in people with General Anesthesia, run by Hallym University Medical Center 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 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: status not confirmed, as of the sponsor's last update on 7 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Mi Kim, Ph.D. (82313803945, sumsonyo@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLE value during induction and emergence of general anesthesia (time frame: Through study completion, an average of fifteen months). 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 7 Feb 2018.