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
Recruitment status was Recruiting
Sponsor:
Stryker Instruments
Information provided by:
Stryker Instruments
ClinicalTrials.gov Identifier:
NCT00829803
First received: January 23, 2009
Last updated: June 22, 2010
Last verified: January 2009
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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
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 June 13, 2013