Sovra and Intra Tentorial LesionsNCT01483547
Reliability of BIS Monitoring in Neurosurgical Patients
An observational study of Sovra and Intra Tentorial Lesions, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sovra and Intra Tentorial Lesions
- What is being tested?
- Bispectral Index (BIS Vista, Covidien)
- Type of treatment
- Medical device
- How many people
- 405 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Dec 2012
- 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: patients undergoing elective craniotomy and elective spinal cord and column surgery.
Who may be able to join
- BIS > 90 at baseline (awake)
- ASA I or II
Who cannot join
- GSC < 15
- anticipated difficult ventilation and/or intubation
- BMI > 30
- surgical site that does not allow BIS monitoring
- bilateral hearing loss
- not speaking Italian Language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.
- Conditions
- Sovra and Intra Tentorial Lesions
- Being tested
- Bispectral Index (BIS Vista, Covidien)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index (BIS Vista, Covidien)Device
BIS values at LOC, PI, ROC.
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgical | Not described Receives: Device: Bispectral Index (BIS Vista, Covidien) | |
| Non-neurosurgical | Not described Receives: Device: Bispectral Index (BIS Vista, Covidien) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS values at LOC, PI and ROC
Measured: 8 months
Secondary outcomes (5)
incidence of intraoperative awareness
intraoperative awareness assessed by BRICE Interview
Measured: 0, 1, 3, 30 days after surgery
incidence of postoperative delirium
assessed by Nursing Delirium Scale and CAM-ICU.
Measured: 0, 1, 3, 30 days after surgery
predicted site effect drugs concentration at LOC, PI and ROC
Propofol and Remifentanil site effect concentrations delivered by TCI.
Measured: 8 months
total amount of anesthetic drugs delivered at the end of surgery
Measured: 8 months
recovery time after surgery
Time needed for the patients to completely regain orientation
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sovra and Intra Tentorial LesionsStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe 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
- 405 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Carozzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483547
- Sponsor's protocol ID
- BISnch2011
- Status last verified
- Feb 2013
- First submitted
- 25 Nov 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT01483547
- Acronym / sponsor ID
- BISnch2011
- Conditions
- Sovra and Intra Tentorial Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Dec 2011 (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 the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurosurgical | – | Device: Bispectral Index (BIS Vista, Covidien) |
| Non-neurosurgical | – | Device: Bispectral Index (BIS Vista, Covidien) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective craniotomy and elective spinal cord and column surgery.
Key inclusion criteria (2 listed)
- BIS > 90 at baseline (awake)
- ASA I or II
Key exclusion criteria (6 listed)
- GSC < 15
- anticipated difficult ventilation and/or intubation
- BMI > 30
- surgical site that does not allow BIS monitoring
- bilateral hearing loss
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 |
|---|---|---|
| Bispectral Index (BIS Vista, Covidien)BIS values at LOC, PI, ROC. | Device | Neurosurgical, Non-neurosurgical |
Primary outcome
BIS values at LOC, PI and ROC
Time frame: 8 months
5 secondary outcomes
incidence of intraoperative awareness
Time frame: 0, 1, 3, 30 days after surgery
incidence of postoperative delirium
Time frame: 0, 1, 3, 30 days after surgery
predicted site effect drugs concentration at LOC, PI and ROC
Time frame: 8 months
total amount of anesthetic drugs delivered at the end of surgery
Time frame: 8 months
recovery time after surgery
Time frame: 8 months
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 18 Feb 2013.
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.
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 Sovra and Intra Tentorial Lesions, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta 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 2 inclusion and 6 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 18 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?
BIS values at LOC, PI and ROC (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2013.