Anesthesia, GeneralPrecision GANCT00829803
A Study to Assess Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
A study testing SNAP monitor; Bispectral Index Monitor (BIS Monitor) in people with Anesthesia, General, run by Stryker Instruments at 4 sites in United States.
Trial summary
Establish the range of index values for the SNAP II corresponding to each anesthetic state studied. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- SNAP monitor; Bispectral Index Monitor (BIS Monitor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2009to Jan 2011
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgery requiring general anesthesia
- Open or laparoscopic procedures
- Cases anticipated to be less than 4 hours in duration
- In-patient and out-patient subjects
- Patients and cases manageable with LMA. Cases manageable with ET tube are also allowed with the condition that only a minimal dose of short-acting NMBA is used at intubation and not throughout the case.
- Local analgesia at incision site is permitted.
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- Males and Females between 18 and 65 years of age, inclusive.
- BMI<40 and body mass>41 kg
- Patients who have signed the informed consent.
- Able to receive Informed Consent through subjects native language providing that a native language speaker delivers the Informed Consent.
- ASA Stratification I - III
Who cannot join
- Any subject failing to fulfill all inclusion criteria
- ASA stratification >= IV
- Subject is a prisoner.
- Patients presenting with evidence of recent trauma, active infection, neurological disorder, seizure disorder, dementia or have been diagnosed with Alzheimer's disease
- Subjects with cardiac or gastric pace makers
- Pregnant women as identified by institutional SOP for female of child-bearing age
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- Patients that will not sign an informed consent form
- Patients with previous adverse incidents with anesthesia, including awareness
- Patients undergoing surgery on the head or neck
- Subjects currently taking psychoactive medications as part of routine medical care within the past 7 days
- Subjects that require and/or receive any of the psychotherapeutic agents or psychotropic drugs below, in the treatment of mental illness, and have taken such treatment within the past 7 days.
- Benzodiazepines
- MAOI inhibitors
- Selective serotonin reuptake inhibitors (SSRIs)
- Tricyclic antidepressants
- Lithium
- Neuroleptic agents
- Central nervous system stimulants.
- Subjects with a known history of alcohol or narcotic abuse within 6 months prior to screening OR subjects reporting narcotic or narcotic medication use with 24 hours prior to surgery.
- Subjects requiring neurophysiologic monitoring
- Subjects requiring TIVA
- Subjects requiring prolonged use of NMBA beyond dose required for intubation
- Subjects requiring ketamine
- Subjects receiving spinal, epidural, or other nerve blocks
- Subjects having any condition or severe illness that to the Principal Investigator's discretion would interfere with study assessments OR other severe acute or chronic medical or psychiatric condition that may interfere with the interpretation of study results and, in the judgment of the investigator, and would make the subject inappropriate for entry into this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
The Ohio State University Medical Center
Columbus, Ohio, 43210
University Of Miami
Miami, Florida, 33101-6370
Beaumont Hospital
Royal Oak, Michigan, 48084
About this study
Official title: A Prospective Randomized Double Blinded Study Assessing Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
Establish the range of index values for the SNAP II corresponding to each anesthetic state studied.
Read the detailed description
Index values for the SNAP II monitor will be identified with each corresponding anesthetic state studied.
- Conditions
- Anesthesia, General
- Being tested
- SNAP monitor; Bispectral Index Monitor (BIS Monitor)
- Keywords
- To acquire developmental data to prospectively support SNAP, II index ranges at the studied anesthetic states.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAP monitor; Bispectral Index Monitor (BIS Monitor)Device
Also called SNAP II monitor, BIS Monitor
Intended to monitor the state of the brain by data acquisition of EEG signals.
| Study group | Role | What they receive |
|---|---|---|
| SNAP Monitor EEG signals | Experimental | Not described Receives: Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor) |
| BIS Monitor EEG signals (VISTA) | Active comparator | Not described Receives: Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNAP Index values corresponding to anesthetic states: Pre-induction (baseline), loss of response, anesthesia maintenance, first purposeful response after anesthesia is discontinued, at extubation or LMA removal
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Instruments
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio D Bergese, M.D., Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829803
- Sponsor's protocol ID
- SIS-SNAP-2008-01US
- Acronym
- Precision GA
- Status last verified
- Jun 2011
- First submitted
- 23 Jan 2009
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergese SD, Uribe AA, Puente EG, Marcus RL, Krohn RJ, Docsa S, Soto RG, Candiotti KA. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia. JMIR Res Protoc. 2017 Feb 3;6(2):e15. doi: 10.2196/resprot.6741.
PubMed 28159731
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blinded Study Assessing Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT00829803
- Acronym / sponsor ID
- Precision GA / SIS-SNAP-2008-01US
- Conditions
- Anesthesia, General
- Keywords
- To acquire developmental data to prospectively support SNAP, II index ranges at the studied anesthetic states.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stryker InstrumentsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Jan 2009 (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.
Establish the range of index values for the SNAP II corresponding to each anesthetic state studied.
Detailed description
Index values for the SNAP II monitor will be identified with each corresponding anesthetic state studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNAP Monitor EEG signals | Experimental | Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor) |
| BIS Monitor EEG signals (VISTA) | Active comparator | Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients scheduled for surgery requiring general anesthesia
- Open or laparoscopic procedures
- Cases anticipated to be less than 4 hours in duration
- In-patient and out-patient subjects
- Patients and cases manageable with LMA. Cases manageable with ET tube are also allowed with the condition that only a minimal dose of short-acting NMBA is used at intubation and not throughout the case.
Key exclusion criteria (25 listed)
- Any subject failing to fulfill all inclusion criteria
- ASA stratification >= IV
- Subject is a prisoner.
- Patients presenting with evidence of recent trauma, active infection, neurological disorder, seizure disorder, dementia or have been diagnosed with Alzheimer's disease
- Subjects with cardiac or gastric pace makers
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 |
|---|---|---|
| SNAP monitor; Bispectral Index Monitor (BIS Monitor)Also: SNAP II monitor, BIS MonitorIntended to monitor the state of the brain by data acquisition of EEG signals. | Device | BIS Monitor EEG signals (VISTA), SNAP Monitor EEG signals |
Primary outcome
SNAP Index values corresponding to anesthetic states: Pre-induction (baseline), loss of response, anesthesia maintenance, first purposeful response after anesthesia is discontinued, at extubation or LMA removal
Time frame: 3 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 9 Nov 2021.
- Derived from this study: PubMed 28159731Bergese SD, Uribe AA, Puente EG, Marcus RL, Krohn RJ, Docsa S, Soto RG, Candiotti KA. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia. JMIR Res Protoc. 2017 Feb 3;6(2):e15. doi: 10.2196/resprot.6741.
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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.
Sergio D Bergese, M.D. study chair
Ohio State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAP monitor; Bispectral Index Monitor (BIS Monitor) in people with Anesthesia, General, run by Stryker Instruments at 4 sites 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 11 inclusion and 25 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
SNAP Index values corresponding to anesthetic states: Pre-induction (baseline), loss of response, anesthesia maintenance, first purposeful response after anesthesia is discontinued, at extubation or LMA removal (time frame: 3 months). 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 NCT00829803, which also lists 1 linked publication.
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 9 Nov 2021.