PainBIS4NCT02585466
BIS and Entropy Nociception Monitoring
An observational study of Pain, run by Medical University of Graz.
Trial summary
Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment" has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty patients, aged 18-65 years, undergoing general surgery on the lower limb were randomly allocated to the BIS 25 or BIS 50 groups
Who may be able to join
- 1. age 18-65 years
Who cannot join
- Alcohol or drug abuse,
- chronic treatment with antihypertensive or cardiovascular medications
- medications acting on the central nervous system such as benzodiazepines, antiepileptic neuroleptics
About this study
Official title: Precise Quantification of Surrogate Nociception Measures "Bispectral Index (sBIS)-Electromyography (sEMG) Variabilities" and "Response Entropy-State Entropy (RE-SE) Difference". A Practice Alignment Study.
Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment" has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating "purely hypothetical" conditions that are not related to "everyday" anesthesia practice.
Read the detailed description
Background: Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment" has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating "purely hypothetical" conditions that are not related to "everyday" anesthesia practice. These proposed new nociception-antinociception parameters are assumed to be "immune" from confounding factors commonly encountered such as neuromuscular block, remifentanil, or cardiovascular haemodynamically active drugs.
Methods: Investigators sought to quantify the basic components of these new nociception-antinociception parameters in response to various noxious stimuli, and then test them against the most confounding factors namely neuromuscular blocking agents (NMBAs) for sEMG, remifentanil analgesia and haemodynamic changes, while at the same time analysing the EEG and blood levels. Investigators examined two nociception -antinociception parameters basic components sBIS/sEMG and Response Entropy-State Entropy difference from the two main manufacturers GE and Medtronic.
Fifty patients, aged 18-65 years, undergoing general surgery on the lower limb were randomly allocated to the BIS 25 or BIS 50 groups. Exclusion criteria included alcohol or drug abuse, chronic treatment with antihypertensive or cardiovascular medications including β-blockers, and medications acting on the central nervous system such as benzodiazepines, antiepileptic and neuroleptic medications, After capnographic verification of proper lungs ventilation with 40% oxygen in air, either BIS 50 levels or BIS 25 were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 of either BIS 50 levels or BIS 25 of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration. Two silver/silver chloride surface stimulating electrodes were placed 4 cm apart on the ulnar nerve at the wrist and connected to Innervator NS272 (Fisher \& Paykel, Auckland, New Zealand) peripheral nerve stimulator. The ulnar nerve was stimulated in an ascending sequence of single twitch electric stimulations starting from 10 mA, up till 80 mA for a period of 10 s with a 3 min period between stimulations. BIS and Entropy data were recorded. After which patients were re-stimulated under remifentanil and again re-stimulated under NMBAs.
- Conditions
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BIS25 | BIS 25 levels were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 ofBIS 25 of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration | |
| BIS50 | BIS 50 levels were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 of either BIS 50 levels of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS (Bispectral Index) variability
Bispectral Index (BIS) difference between the highest and lowest values
Measured: 3 minutes following a 10 seconds stimulation
Secondary outcomes (2)
EMG variability
Electromypgraphy (EMG) difference between the highest and lowest values
Measured: 3 minutes following a 10 seconds stimulation
Response Entropy - State Entropy difference (RE-SE)
Difference between Respnse Entropy value (RE, derived from electroencephalography and electromyography) minus State Entropy (SE, derived from electroencephalography only)
Measured: 3 minutes following a 10 seconds stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Dahaba, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585466
- Sponsor's protocol ID
- MUGraz4
- Acronym
- BIS4
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen P. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. Acta Anaesthesiol Scand. 2004 Feb;48(2):154-61. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
PubMed 14995936Sigl JC, Chamoun NG. An introduction to bispectral analysis for the electroencephalogram. J Clin Monit. 1994 Nov;10(6):392-404. doi: 10.1007/BF01618421.
PubMed 7836975Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-773. doi: 10.1213/01.ane.0000167269.62966.af.
PubMed 16115989
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Quantification of Surrogate Nociception Measures "Bispectral Index (sBIS)-Electromyography (sEMG) Variabilities" and "Response Entropy-State Entropy (RE-SE) Difference". A Practice Alignment Study.
- ClinicalTrials.gov ID
- NCT02585466
- Acronym / sponsor ID
- BIS4 / MUGraz4
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 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.
Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment" has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating "purely hypothetical" conditions that are not related to "everyday" anesthesia practice.
Detailed description
Background: Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment" has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating "purely hypothetical" conditions that are not related to "everyday" anesthesia practice. These proposed new nociception-antinociception parameters are assumed to be "immune" from confounding factors commonly encountered such as neuromuscular block, remifentanil, or cardiovascular haemodynamically active drugs.
Methods: Investigators sought to quantify the basic components of these new nociception-antinociception parameters in response to various noxious stimuli, and then test them against the most confounding factors namely neuromuscular blocking agents (NMBAs) for sEMG, remifentanil analgesia and haemodynamic changes, while at the same time analysing the EEG and blood levels. Investigators examined two nociception -antinociception parameters basic components sBIS/sEMG and Response Entropy-State Entropy difference from the two main manufacturers GE and Medtronic.
Fifty patients, aged 18-65 years, undergoing general surgery on the lower limb were randomly allocated to the BIS 25 or BIS 50 groups. Exclusion criteria included alcohol or drug abuse, chronic treatment with antihypertensive or cardiovascular medications including β-blockers, and medications acting on the central nervous system such as benzodiazepines, antiepileptic and neuroleptic medications, After capnographic verification of proper lungs ventilation with 40% oxygen in air, either BIS 50 levels or BIS 25 were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 of either BIS 50 levels or BIS 25 of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration. Two silver/silver chloride surface stimulating electrodes were placed 4 cm apart on the ulnar nerve at the wrist and connected to Innervator NS272 (Fisher \& Paykel, Auckland, New Zealand) peripheral nerve stimulator. The ulnar nerve was stimulated in an ascending sequence of single twitch electric stimulations starting from 10 mA, up till 80 mA for a period of 10 s with a 3 min period between stimulations. BIS and Entropy data were recorded. After which patients were re-stimulated under remifentanil and again re-stimulated under NMBAs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS25 | – | –BIS 25 levels were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 ofBIS 25 of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration |
| BIS50 | – | –BIS 50 levels were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 of either BIS 50 levels of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty patients, aged 18-65 years, undergoing general surgery on the lower limb were randomly allocated to the BIS 25 or BIS 50 groups
Key inclusion criteria (1 listed)
- 1. age 18-65 years
Key exclusion criteria (3 listed)
- Alcohol or drug abuse,
- chronic treatment with antihypertensive or cardiovascular medications
- medications acting on the central nervous system such as benzodiazepines, antiepileptic neuroleptics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BIS (Bispectral Index) variability
Time frame: 3 minutes following a 10 seconds stimulation
Bispectral Index (BIS) difference between the highest and lowest values
2 secondary outcomes
EMG variability
Time frame: 3 minutes following a 10 seconds stimulation
Response Entropy - State Entropy difference (RE-SE)
Time frame: 3 minutes following a 10 seconds stimulation
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 26 Oct 2015.
- Background: PubMed 14995936Viertio-Oja H, Maja V, Sarkela M, Talja P, Tenkanen N, Tolvanen-Laakso H, Paloheimo M, Vakkuri A, Yli-Hankala A, Merilainen P. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. Acta Anaesthesiol Scand. 2004 Feb;48(2):154-61. doi: 10.1111/j.0001-5172.2004.00322.x. No abstract available.
- Background: PubMed 7836975Sigl JC, Chamoun NG. An introduction to bispectral analysis for the electroencephalogram. J Clin Monit. 1994 Nov;10(6):392-404. doi: 10.1007/BF01618421.
- Background: PubMed 16115989Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-773. doi: 10.1213/01.ane.0000167269.62966.af.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Medical University of Graz.
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: finished, as of the sponsor's last update on 26 Oct 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.
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?
BIS (Bispectral Index) variability (time frame: 3 minutes following a 10 seconds stimulation). 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 NCT02585466, which also lists 3 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 26 Oct 2015.