Consciousness, Level DepressedNCT01800578
Awareness During Blended Anaesthesia
An observational study of Consciousness, Level Depressed and Intraoperative Awareness, run by Germano De Cosmo at 1 site in Italy.
Trial summary
the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Consciousness, Level Depressed, Intraoperative Awareness
- What is being tested?
- monitor for depth of hypnosis
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2005to Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective major abdominal surgery
Who may be able to join
- native Italian speakers American society of anaesthesiologist physical status I-II -
- Exclusion Criteria:refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationships Between Bispectral Index (BIS), Implicit Memory Dream Recall and MAC in Blended Anaesthesia
the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.
Read the detailed description
The decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations.
Awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia.
Different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness .
This memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (PTSD) in more than half of subjects .
Some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used.
The Bispectral Index ( BIS ), one of the devices designed to monitor brain activity, through a proprietary algorithm , elaborates EEG and provides an index of hypnotic level.
Thus, several variables, derived from EEG time and frequency domain, are combined into a single index indicating the patient's level of consciousness.
A range between 40 and 60, during surgery, permits both to prevent awareness and to reduce the dose of anesthetic agent administered .
In this study, during major abdominal surgery, an epidural analgesia was performed to suppress afferent noxious stimuli and combined with a general anaesthesia based on halogenates.
Thereby the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.
- Being tested
- monitor for depth of hypnosis
- Keywords
- Cerebral State Index Monitor
- Medical subject headings
- Consciousness Disorders, Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitor for depth of hypnosisDevice
evaluation of depth of hypnosis
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| Bispectral Index Group | Not described Receives: Device: monitor for depth of hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between BIS and free association test score
Measured: every 15 min during anaesthesia and 24 h after emergency from anaesthesia
Secondary outcomes (1)
MAC of sevoflurane necessary to avoid awareness
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 posted27 Feb 2013 (estimated)
- Study startSep 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Consciousness, Level DepressedStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germano De Cosmo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Germano De Cosmo, Catholic University of the Sacred Heart
- Investigators
- De Cosmo Germano, PhD, Principal investigator, Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800578
- Sponsor's protocol ID
- A1044/2001
- Status last verified
- Feb 2013
- First submitted
- 12 Nov 2012
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong CS. What's the matter of depth of anesthesia? Acta Anaesthesiol Sin. 2001 Mar;39(1):1-2. No abstract available.
PubMed 11407288Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
PubMed 10703802Schwender D, Klasing S, Daunderer M, Madler C, Poppel E, Peter K. [Awareness during general anesthesia. Definition, incidence, clinical relevance, causes, avoidance and medicolegal aspects]. Anaesthesist. 1995 Nov;44(11):743-54. doi: 10.1007/s001010050209. German.
PubMed 8678265Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. doi: 10.1016/s0163-8343(01)00142-6.
PubMed 11543846Baars BJ. The brain basis of a "consciousness monitor": scientific and medical significance. Conscious Cogn. 2001 Jun;10(2):159-64; discussion 246-58. doi: 10.1006/ccog.2001.0510.
PubMed 11414712Ghoneim 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 17900012Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.
PubMed 14674969Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.
PubMed 12697591
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Bispectral Index (BIS), Implicit Memory Dream Recall and MAC in Blended Anaesthesia
- ClinicalTrials.gov ID
- NCT01800578
- Acronym / sponsor ID
- A1044/2001
- Keywords
- Cerebral State Index Monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Germano De CosmoUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Feb 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 relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.
Detailed description
The decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations.
Awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia.
Different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness .
This memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (PTSD) in more than half of subjects .
Some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used.
The Bispectral Index ( BIS ), one of the devices designed to monitor brain activity, through a proprietary algorithm , elaborates EEG and provides an index of hypnotic level.
Thus, several variables, derived from EEG time and frequency domain, are combined into a single index indicating the patient's level of consciousness.
A range between 40 and 60, during surgery, permits both to prevent awareness and to reduce the dose of anesthetic agent administered .
In this study, during major abdominal surgery, an epidural analgesia was performed to suppress afferent noxious stimuli and combined with a general anaesthesia based on halogenates.
Thereby the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bispectral Index Group | – | Device: monitor for depth of hypnosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective major abdominal surgery
Key inclusion criteria (3 listed)
- native Italian speakers American society of anaesthesiologist physical status I-II -
- Exclusion Criteria:refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| monitor for depth of hypnosisevaluation of depth of hypnosis -------------------------------------------------------------------------------- | Device | Bispectral Index Group |
Primary outcome
correlation between BIS and free association test score
Time frame: every 15 min during anaesthesia and 24 h after emergency from anaesthesia
1 secondary outcome
MAC of sevoflurane necessary to avoid awareness
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 27 Feb 2013.
- Background: PubMed 11407288Wong CS. What's the matter of depth of anesthesia? Acta Anaesthesiol Sin. 2001 Mar;39(1):1-2. No abstract available.
- Background: PubMed 10703802Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
- Background: PubMed 8678265Schwender D, Klasing S, Daunderer M, Madler C, Poppel E, Peter K. [Awareness during general anesthesia. Definition, incidence, clinical relevance, causes, avoidance and medicolegal aspects]. Anaesthesist. 1995 Nov;44(11):743-54. doi: 10.1007/s001010050209. German.
- Background: PubMed 11543846Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. doi: 10.1016/s0163-8343(01)00142-6.
- Background: PubMed 11414712Baars BJ. The brain basis of a "consciousness monitor": scientific and medical significance. Conscious Cogn. 2001 Jun;10(2):159-64; discussion 246-58. doi: 10.1006/ccog.2001.0510.
- 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 14674969Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.
- Background: PubMed 12697591Aceto P, Valente A, Gorgoglione M, Adducci E, De Cosmo G. Relationship between awareness and middle latency auditory evoked responses during surgical anaesthesia. Br J Anaesth. 2003 May;90(5):630-5. doi: 10.1093/bja/aeg113.
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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
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 Consciousness, Level Depressed and Intraoperative Awareness, run by Germano De Cosmo at 1 site 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 3 inclusion and 0 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 27 Feb 2013. 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 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?
correlation between BIS and free association test score (time frame: every 15 min during anaesthesia and 24 h after emergency from anaesthesia). 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 NCT01800578, which also lists 8 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 27 Feb 2013.