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Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Anesthesia

Research Study Title

A Prospective Randomized Double Blinded Study Assessing Indeics of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia

Purpose

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

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 to 65 Years

Overall Status

Recruiting

Lead Sponsor

Stryker Instruments

Duration

17 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 65 Years

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.

Site Locations (4)

Country State City Zip Facility and Contact
United States Florida Miami 33101-6370 University Of Miami
Keith Candiotti, MD
305-585-5332
kcandiotti@miami.edu

Keith Candiotti, MD
Principal Investigator
United States Illinois Chicago 60611 Northwestern University Feinberg School of Medicine
Robert McCarthy, PharmD
312-926-9015
r-mccarthy@northwestern.edu

Robert McCarthy, Pharm. D.
Principal Investigator
United States Michigan Royal Oak 48084 Beaumont Hospital
Roy Soto, MD
248-458-0400
roysoto@gmail.com

Roy Soto, MD
Principal Investigator
United States Ohio Columbus 43210 The Ohio State University Medical Center
Erika G Puente, MD
614-293-8487
erika.puente@osumc.edu

Erika G Puente, MD
Principal Investigator

NCT ID: NCT00829803

Date Last Changed: June 22, 2010

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