A Study to Assess Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
NCT ID: NCT00829803
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-02-28
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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SNAP Monitor EEG signals
SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intended to monitor the state of the brain by data acquisition of EEG signals.
BIS Monitor EEG signals (VISTA)
SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intended to monitor the state of the brain by data acquisition of EEG signals.
Interventions
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SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intended to monitor the state of the brain by data acquisition of EEG signals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Stryker Instruments
INDUSTRY
Responsible Party
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Principal Investigators
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Sergio D Bergese, M.D.
Role: STUDY_CHAIR
Ohio State University
Locations
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University Of Miami
Miami, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Beaumont Hospital
Royal Oak, Michigan, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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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.
Other Identifiers
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SIS-SNAP-2008-01US
Identifier Type: -
Identifier Source: org_study_id