Intraoperative AwarenessNCT01868178
Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia
An observational study of Intraoperative Awareness, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial summary
The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Intraoperative Awareness
- What is being tested?
- BIS and Spectral Entropy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2008to Jan 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: female patients, aged 30-60 years , scheduled for minor elective surgery lasts between 1 and 3 hours were enrolled.
Who may be able to join
- American society of anesthesiologist physical status I-II
- Italian native speakers
Who cannot join
- Psychiatric or neurologic diseases
- Acoustic impairment
- Obesity (Body Mass Index > 30)
- Substance dependence.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Catholic University of Sacred Heart
Rome, Rm, 00168
Catholic University
Rome, Rm, 00168
About this study
The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.
Read the detailed description
During the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia.
Awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events.
Different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness.
To assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". These result easy to use and reliable in detect implicit memory.
Bispectral Index (BIS) and Spectral Entropy (SpEn) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth.
The bispectral index is a monitor of anaesthetic depth approved by the Food and Drug Administration in the USA. The BIS monitor reports a dimensionless number between 0 (complete EEG inactivity) and 100 (awake state); BIS values from 40 to 60 are thought to be suitable for general anaesthesia. Spectral Entropy acquires the electroencephalograph (EEG) and frontal electromyography (FEMG) signals which are processed into three parameters: State Entropy (SE), Response Entropy (RE) and Burst Suppression Ratio (BSR).
SE is computed over the EEG dominant part of the spectrum (0.8-32 Hz), and therefore primarily should reflect the cortical state of the patient and results useful to assess hypnotic effects of drugs .
RE is computed over a frequency range from 0.8 to47 Hz. It includes both the EEG-dominant and EMG-dominant part of the spectrum . The SE and RE values below 60 correlate with a low probability of consciousness. Also Bispectral Index provides BRS, an evaluation of burst suppression in which cerebral activity results suppressed.
BIS and Spectral Entropy are intended to decrease the risk of intraoperative awareness and to enable the anesthetist to reduce risk of the under- and overdosing of anesthetic agents and to ensure faster and more predictable wake-up and extubation.
Previous studies result contrasting in the correlation between these devices with lack in evaluation of implicit memory.
The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.
- Conditions
- Intraoperative Awareness
- Being tested
- BIS and Spectral Entropy
- Keywords
- awareness
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS and Spectral EntropyDevice
The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness
| Study group | Role | What they receive |
|---|---|---|
| BIS Spectral Entropy Group | intraoperative monitoring with BIS and Spectral Entropy Receives: Device: BIS and Spectral Entropy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS index
Measured: change from baseline at 15 min
Secondary outcomes (1)
entropy values
Measured: 24 h after emergency from anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intraoperative AwarenessStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germano De Cosmo, Catholic University of the Sacred Heart
- Investigators
- De Cosmo Germano, PhD, Principal investigator, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868178
- Sponsor's protocol ID
- A 935/2007
- Status last verified
- May 2013
- First submitted
- 12 Nov 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.
PubMed 10201677Heier T, Steen PA. Awareness in anaesthesia: incidence, consequences and prevention. Acta Anaesthesiol Scand. 1996 Oct;40(9):1073-86. doi: 10.1111/j.1399-6576.1996.tb05569.x.
PubMed 8933848Liu WH, Thorp TA, Graham SG, Aitkenhead AR. Incidence of awareness with recall during general anaesthesia. Anaesthesia. 1991 Jun;46(6):435-7. doi: 10.1111/j.1365-2044.1991.tb11677.x.
PubMed 2048657O'Connor MF, Daves SM, Tung A, Cook RI, Thisted R, Apfelbaum J. BIS monitoring to prevent awareness during general anesthesia. Anesthesiology. 2001 Mar;94(3):520-2. doi: 10.1097/00000542-200103000-00025.
PubMed 11374615Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.
PubMed 5423844Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.
PubMed 9585303Ghoneim MM. Incidence of and risk factors for awareness during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):327-43. doi: 10.1016/j.bpa.2007.05.002.
PubMed 17900012Kissin I. Depth of anesthesia and bispectral index monitoring. Anesth Analg. 2000 May;90(5):1114-7. doi: 10.1097/00000539-200005000-00021. No abstract available.
PubMed 10781463Paolo Martorano P, Falzetti G, Pelaia P. Bispectral index and spectral entropy in neuroanesthesia. J Neurosurg Anesthesiol. 2006 Jul;18(3):205-10. doi: 10.1097/01.ana.0000206229.38883.d2.
PubMed 16799349Liu J, Singh H, White PF. Electroencephalographic bispectral index correlates with intraoperative recall and depth of propofol-induced sedation. Anesth Analg. 1997 Jan;84(1):185-9. doi: 10.1097/00000539-199701000-00033.
PubMed 8989022
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia
- ClinicalTrials.gov ID
- NCT01868178
- Acronym / sponsor ID
- A 935/2007
- Conditions
- Intraoperative Awareness
- Keywords
- awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Jun 2013 (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 aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.
Detailed description
During the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia.
Awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events.
Different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness.
To assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". These result easy to use and reliable in detect implicit memory.
Bispectral Index (BIS) and Spectral Entropy (SpEn) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth.
The bispectral index is a monitor of anaesthetic depth approved by the Food and Drug Administration in the USA. The BIS monitor reports a dimensionless number between 0 (complete EEG inactivity) and 100 (awake state); BIS values from 40 to 60 are thought to be suitable for general anaesthesia. Spectral Entropy acquires the electroencephalograph (EEG) and frontal electromyography (FEMG) signals which are processed into three parameters: State Entropy (SE), Response Entropy (RE) and Burst Suppression Ratio (BSR).
SE is computed over the EEG dominant part of the spectrum (0.8-32 Hz), and therefore primarily should reflect the cortical state of the patient and results useful to assess hypnotic effects of drugs .
RE is computed over a frequency range from 0.8 to47 Hz. It includes both the EEG-dominant and EMG-dominant part of the spectrum . The SE and RE values below 60 correlate with a low probability of consciousness. Also Bispectral Index provides BRS, an evaluation of burst suppression in which cerebral activity results suppressed.
BIS and Spectral Entropy are intended to decrease the risk of intraoperative awareness and to enable the anesthetist to reduce risk of the under- and overdosing of anesthetic agents and to ensure faster and more predictable wake-up and extubation.
Previous studies result contrasting in the correlation between these devices with lack in evaluation of implicit memory.
The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS Spectral Entropy Group | – | Device: BIS and Spectral Entropyintraoperative monitoring with BIS and Spectral Entropy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patients, aged 30-60 years , scheduled for minor elective surgery lasts between 1 and 3 hours were enrolled.
Key inclusion criteria (2 listed)
- American society of anesthesiologist physical status I-II
- Italian native speakers
Key exclusion criteria (4 listed)
- Psychiatric or neurologic diseases
- Acoustic impairment
- Obesity (Body Mass Index > 30)
- Substance dependence.
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 |
|---|---|---|
| BIS and Spectral EntropyThe aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness | Device | BIS Spectral Entropy Group |
Primary outcome
BIS index
Time frame: change from baseline at 15 min
1 secondary outcome
entropy values
Time frame: 24 h after emergency from anaesthesia
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 4 Jun 2013.
- Background: PubMed 10201677Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.
- Background: PubMed 8933848Heier T, Steen PA. Awareness in anaesthesia: incidence, consequences and prevention. Acta Anaesthesiol Scand. 1996 Oct;40(9):1073-86. doi: 10.1111/j.1399-6576.1996.tb05569.x.
- Background: PubMed 2048657Liu WH, Thorp TA, Graham SG, Aitkenhead AR. Incidence of awareness with recall during general anaesthesia. Anaesthesia. 1991 Jun;46(6):435-7. doi: 10.1111/j.1365-2044.1991.tb11677.x.
- Background: PubMed 11374615O'Connor MF, Daves SM, Tung A, Cook RI, Thisted R, Apfelbaum J. BIS monitoring to prevent awareness during general anesthesia. Anesthesiology. 2001 Mar;94(3):520-2. doi: 10.1097/00000542-200103000-00025.
- Background: PubMed 5423844Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.
- Background: PubMed 9585303Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.
- Background: PubMed 17900012Ghoneim MM. Incidence of and risk factors for awareness during anaesthesia. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):327-43. doi: 10.1016/j.bpa.2007.05.002.
- Background: PubMed 10781463Kissin I. Depth of anesthesia and bispectral index monitoring. Anesth Analg. 2000 May;90(5):1114-7. doi: 10.1097/00000539-200005000-00021. No abstract available.
- Background: PubMed 16799349Paolo Martorano P, Falzetti G, Pelaia P. Bispectral index and spectral entropy in neuroanesthesia. J Neurosurg Anesthesiol. 2006 Jul;18(3):205-10. doi: 10.1097/01.ana.0000206229.38883.d2.
- Background: PubMed 8989022Liu J, Singh H, White PF. Electroencephalographic bispectral index correlates with intraoperative recall and depth of propofol-induced sedation. Anesth Analg. 1997 Jan;84(1):185-9. doi: 10.1097/00000539-199701000-00033.
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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.
De Cosmo Germano, PhD principal investigator
Catholic University of Sacred Heart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Awareness, run by Catholic University of the Sacred Heart at 2 sites in Italy.
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 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: finished, as of the sponsor's last update on 4 Jun 2013. 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 Italy. 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?
BIS index (time frame: change from baseline at 15 min). 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 NCT01868178, which also lists 10 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 4 Jun 2013.