General AnesthesiaNCT00599066
Intraoperative M-Entropy Measurements
An observational study of General Anesthesia, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- study cases
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2009
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are scheduled to have surgery under general anesthesia for which an intraoperative M-Entropy monitoring is planned. Suitable candidates will be identified by speaking to the attending anesthesiologists working at OU Presbyterian hospital.
Who may be able to join
- Patients scheduled to have surgery under general anesthesia, with a minimum of 60 minutes expected duration.
Who cannot join
- Non-English speaker
- Patients younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
OU MEDICAL CENTER, Presbyterian Tower, OR
Oklahoma City, Oklahoma, 73104
About this study
Official title: Same-patient Reproducibility of Intraoperative M-Entropy Measurements
The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using.
Read the detailed description
Depth of anesthesia monitors are increasingly used in clinical anesthesia practice. Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG to derive a number indicating the anesthetic depth. These devices have similar disposable skin probes that can be applied on either side of the forehead. Since the depth of anesthesia for an individual is the same over the whole brain cortex at a given point in time, BIS numbers obtained over the left and right side of the forehead should agree. The same should be true for M-Entropy as well.
A recent study, however, showed that two separate BIS probes, applied over the left and right forehead of the same patient at the same time, can give significantly different numbers. This has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms that process the raw EEG signal to compute a numeric value. Therefore, it is possible that M-Entropy may show different results in a similar study setup.
The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and recording Entropy variables over both the left and the right side of the forehead of patients under general anesthesia.
- Conditions
- General Anesthesia
- Being tested
- study cases
- Keywords
- M-Entropy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study casesDevice
Also called M-entropy module (Datex-Ohmeda S/5 EntropyTM Module)
Application of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Study cases | Application of a second M-Entropy probe on the forehead of the patient; at the end the patient will have 2 probes on the forehead, one in the right and one in the left. Receives: Device: study cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehemet Ozcan, MD, Principal investigator, The University of Oklahoma Health Sciences Center, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599066
- Sponsor's protocol ID
- IRB No: 13577
- Status last verified
- Apr 2017
- First submitted
- 20 Dec 2007
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Niedhart DJ, Kaiser HA, Jacobsohn E, Hantler CB, Evers AS, Avidan MS. Intrapatient reproducibility of the BISxp monitor. Anesthesiology. 2006 Feb;104(2):242-8. doi: 10.1097/00000542-200602000-00007.
PubMed 16436841Ozcan MS, Gravenstein D. The presence of working memory without explicit recall in a critically ill patient. Anesth Analg. 2004 Feb;98(2):469-470. doi: 10.1213/01.ANE.0000096184.32247.D0.
PubMed 14742389
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-patient Reproducibility of Intraoperative M-Entropy Measurements
- ClinicalTrials.gov ID
- NCT00599066
- Acronym / sponsor ID
- IRB No: 13577
- Conditions
- General Anesthesia
- Keywords
- M-Entropy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jan 2008 (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 purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using.
Detailed description
Depth of anesthesia monitors are increasingly used in clinical anesthesia practice. Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG to derive a number indicating the anesthetic depth. These devices have similar disposable skin probes that can be applied on either side of the forehead. Since the depth of anesthesia for an individual is the same over the whole brain cortex at a given point in time, BIS numbers obtained over the left and right side of the forehead should agree. The same should be true for M-Entropy as well.
A recent study, however, showed that two separate BIS probes, applied over the left and right forehead of the same patient at the same time, can give significantly different numbers. This has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms that process the raw EEG signal to compute a numeric value. Therefore, it is possible that M-Entropy may show different results in a similar study setup.
The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and recording Entropy variables over both the left and the right side of the forehead of patients under general anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cases | – | Device: study casesApplication of a second M-Entropy probe on the forehead of the patient; at the end the patient will have 2 probes on the forehead, one in the right and one in the left. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are scheduled to have surgery under general anesthesia for which an intraoperative M-Entropy monitoring is planned. Suitable candidates will be identified by speaking to the attending anesthesiologists working at OU Presbyterian hospital.
Key inclusion criteria (1 listed)
- Patients scheduled to have surgery under general anesthesia, with a minimum of 60 minutes expected duration.
Key exclusion criteria (2 listed)
- Non-English speaker
- Patients younger than 18 years of age
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 |
|---|---|---|
| study casesAlso: M-entropy module (Datex-Ohmeda S/5 EntropyTM Module)Application of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia. | Device | Study cases |
Primary outcome
The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.
Time frame: 1 year
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 14 Apr 2017.
- Background: PubMed 16436841Niedhart DJ, Kaiser HA, Jacobsohn E, Hantler CB, Evers AS, Avidan MS. Intrapatient reproducibility of the BISxp monitor. Anesthesiology. 2006 Feb;104(2):242-8. doi: 10.1097/00000542-200602000-00007.
- Background: PubMed 14742389Ozcan MS, Gravenstein D. The presence of working memory without explicit recall in a critically ill patient. Anesth Analg. 2004 Feb;98(2):469-470. doi: 10.1213/01.ANE.0000096184.32247.D0.
- 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.
Mehemet Ozcan, MD principal investigator
The University of Oklahoma Health Sciences Center, Department of Anesthesiology
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 General Anesthesia, run by University of Oklahoma at 1 site in United States.
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 2 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 14 Apr 2017. 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 United States. 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?
The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia. (time frame: 1 year). 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 NCT00599066, which also lists 2 linked publications.
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 Apr 2017.