A Study to Assess Indeics of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia (Precision GA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Stryker Instruments.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stryker Instruments
ClinicalTrials.gov Identifier:
NCT00829803
First received: January 23, 2009
Last updated: June 22, 2010
Last verified: January 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
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
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNAP Monitor EEG signals Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor)
Intended to monitor the state of the brain by data acquisition of EEG signals.
Active Comparator: BIS Monitor EEG signals (VISTA) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829803

Locations
United States, Florida
University Of Miami Recruiting
Miami, Florida, United States, 33101-6370
Contact: Keith Candiotti, MD    305-585-5332    kcandiotti@miami.edu   
Principal Investigator: Keith Candiotti, MD         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert McCarthy, PharmD    312-926-9015    r-mccarthy@northwestern.edu   
Principal Investigator: Robert McCarthy, Pharm. D.         
United States, Michigan
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48084
Contact: Roy Soto, MD    248-458-0400    roysoto@gmail.com   
Principal Investigator: Roy Soto, MD         
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Erika G Puente, MD    614-293-8487    erika.puente@osumc.edu   
Principal Investigator: Erika G Puente, MD         
Sponsors and Collaborators
Stryker Instruments
  More Information

No publications provided

Responsible Party: Stryker Instruments
ClinicalTrials.gov Identifier: NCT00829803     History of Changes
Other Study ID Numbers: SIS-SNAP-2008-01US
Study First Received: January 23, 2009
Last Updated: June 22, 2010
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.

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014