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A Study Assessing Indices of Stryker National Attitudes and Perceptions (SNAP) Versus VISTA (Precision GA)
This study is not yet open for participant recruitment.
Verified by Stryker Instruments, January 2009
Sponsored by: Stryker Instruments
Information provided by: Stryker Instruments
ClinicalTrials.gov Identifier: NCT00829803
  Purpose

Establish the range of index values for the SNAP II corresponding to each anesthetic state studied.


Condition Intervention Phase
Anesthesia
Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Phase IV

MedlinePlus related topics: Anesthesia
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Parallel Assignment
Official Title: A Prospective Randomized Double Blinded Study Assessing Indeics of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia

Further study details as provided by Stryker Instruments:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Arms Assigned Interventions
SNAP Monitor EEG signals: Experimental Device: 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): Active Comparator Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intended to monitor the state of the brain by data acquisition of EEG signals.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829803

Locations
United States, Florida
University Of Miami
Miami, Florida, United States, 33101-6370
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48084
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Stryker Instruments
  More Information

Responsible Party: Stryker Instruments ( Stryker Instruments )
Study ID Numbers: SIS-SNAP-2008-01US
Study First Received: January 23, 2009
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00829803  
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Instruments:
To acquire developmental data to prospectively support SNAP
II index ranges at the studied anesthetic states.

ClinicalTrials.gov processed this record on January 30, 2009