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

November 2, 2021 updated by: Stryker Instruments

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Index values for the SNAP II monitor will be identified with each corresponding anesthetic state studied.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33101-6370
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Michigan
      • Royal Oak, Michigan, United States, 48084
        • Beaumont Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • SNAP II monitor
  • BIS Monitor
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.
Other Names:
  • SNAP II monitor
  • BIS Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Instruments

Investigators

  • Study Chair: Sergio D Bergese, M.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (ESTIMATE)

January 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIS-SNAP-2008-01US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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