AnesthesiaPhase 4NCT02586441
Evaluation of EEG With Respect to the Change of Depth of Anesthesia During General Anesthesia
A Phase 4 study testing Electroencephalography, Propofol and Rocuronium bromide in people with Anesthesia, run by Korea University Anam Hospital.
Trial summary
The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Electroencephalography, Propofol and Rocuronium bromide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2017
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologist[ASA] class 1-2
- written informed consent
Who cannot join
- allergy of neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- suspected difficult tracheal intubation
- Uncontrolled Hypertension
- known or suspected psychologic disorder
- known or suspected significant renal dysfunction
- known or suspected severe hepatic dysfunction
- known or suspected significant cardiovascular dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of EEG With Respect to the Change of Depth of Anesthesia
The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported.
Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.
Read the detailed description
General anesthesia is accompanied during surgery gives a lot of satisfaction and impact on surgical outcomes of patients depending on the dose of the anesthetic, as well as operation time and intensity.
The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported.
Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.
- Conditions
- Anesthesia
- Being tested
- Electroencephalography, Propofol, Rocuronium bromide
- Keywords
- Bispectral index (BIS), EEG, Depth of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during all anesthetic period.
PropofolDrug
Also called Fresofol MCT 1%
intravenous 1% propofol (1.5-2.5 mg/kg)
Rocuronium bromideDrug
Also called Esmerone
intravenous rocuronium bromide (0.6 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Electroencephalography | Experimental | 1. Standard monitoring included electrocardiogram, noninvasive arterial blood pressure, pulse oximetry, and BIS-VISTATM sensor at OR.
2. Raw EEG in a steady state was collected for 5 minutes.
3. Anesthesia was induced with intravenous 1% propofol (1.5-2.5 mg/kg) and rocuronium bromide (0.6 mg/kg)
4. Mechanical ventilation was initiated
5. Anesthesia was maintained with desflurane at an end-tidal concentration of 6-7 %, with a fraction of inspired oxygen of 0.5 (fresh gas flow; O2 1.5 L/min and air 2.5 L/min).
6. On completion of the surgery, all anesthetic gases were discontinued and the FiO2 was increased to 1.0.
7. After extubation, BIS-VISTA TM monitoring was stopped. Receives: Device: Electroencephalography; Drug: Propofol; Drug: Rocuronium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG acquisition
Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during intraoperative period.
Transferring the raw EEG signal obtained from BIS VISTA monitor to a computer, the data is processed using MATLAB
Measured: From 5minutes before induction to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (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 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joonchul Jang, Korea University Anam Hospital
- Investigators
- Hyub Huh, M.D, Principal investigator, Anesthesia and Pain medicine department, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586441
- Sponsor's protocol ID
- MD11004
- Status last verified
- Nov 2015
- First submitted
- 23 Oct 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon YG, Kim TH, Jeong DW, Park SH. Monitoring the depth of anesthesia from rat EEG using modified Shannon entropy analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:4386-9. doi: 10.1109/IEMBS.2011.6091088.
PubMed 22255311
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EEG With Respect to the Change of Depth of Anesthesia
- ClinicalTrials.gov ID
- NCT02586441
- Acronym / sponsor ID
- MD11004
- Conditions
- Anesthesia
- Keywords
- Bispectral index (BIS), EEG, Depth of anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 26 Oct 2015 (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 BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported.
Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.
Detailed description
General anesthesia is accompanied during surgery gives a lot of satisfaction and impact on surgical outcomes of patients depending on the dose of the anesthetic, as well as operation time and intensity.
The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time.
However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported.
Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electroencephalography | Experimental | Device: Electroencephalography, Drug: Propofol, Drug: Rocuronium bromide1. Standard monitoring included electrocardiogram, noninvasive arterial blood pressure, pulse oximetry, and BIS-VISTATM sensor at OR. 2. Raw EEG in a steady state was collected for 5 minutes. 3. Anesthesia was induced with intravenous 1% propofol (1.5-2.5 mg/kg) and rocuronium bromide (0.6 mg/kg) 4. Mechanical ventilation was initiated 5. Anesthesia was maintained with desflurane at an end-tidal concentration of 6-7 %, with a fraction of inspired oxygen of 0.5 (fresh gas flow; O2 1.5 L/min and air 2.5 L/min). 6. On completion of the surgery, all anesthetic gases were discontinued and the FiO2 was increased to 1.0. 7. After extubation, BIS-VISTA TM monitoring was stopped. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist[ASA] class 1-2
- written informed consent
Key exclusion criteria (8 listed)
- allergy of neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- suspected difficult tracheal intubation
- Uncontrolled Hypertension
- known or suspected psychologic disorder
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 |
|---|---|---|
| ElectroencephalographyRaw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during all anesthetic period. | Device | Electroencephalography |
| PropofolAlso: Fresofol MCT 1%intravenous 1% propofol (1.5-2.5 mg/kg) | Drug | Electroencephalography |
| Rocuronium bromideAlso: Esmeroneintravenous rocuronium bromide (0.6 mg/kg) | Drug | Electroencephalography |
Primary outcome
EEG acquisition
Time frame: From 5minutes before induction to extubation
Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during intraoperative period. Transferring the raw EEG signal obtained from BIS VISTA monitor to a computer, the data is processed using MATLAB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Results publication: PubMed 22255311Yoon YG, Kim TH, Jeong DW, Park SH. Monitoring the depth of anesthesia from rat EEG using modified Shannon entropy analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:4386-9. doi: 10.1109/IEMBS.2011.6091088.
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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.
Hyub Huh, M.D principal investigator
Anesthesia and Pain medicine department, Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electroencephalography, Propofol and Rocuronium bromide in people with Anesthesia, run by Korea University Anam Hospital.
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 8 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 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyub Huh, M.D (+82 - 10 - 6212 -9105, clumania@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG acquisition (time frame: From 5minutes before induction to extubation). 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 NCT02586441, 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 4 Nov 2015.