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

Stryker

Status

Completed

Conditions

Anesthesia, General

Treatments

Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00829803

SIS-SNAP-2008-01US

Details and patient eligibility

About

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

Full description

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

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.