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

• Sponsor: Stryker Instruments (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00829803
• Collaborator: (none)
• Enrollment: 40
• Locations: 4
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 10
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General	Device: SNAP monitor; Bispectral Index Monitor (BIS Monitor)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: A Prospective Randomized Double Blinded Study Assessing Indices of SNAP vs VISTA on Surgical Patients Undergoing General Anesthesia
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Of Miami	Miami	Florida	United States	33101-6370
2	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
3	Beaumont Hospital	Royal Oak	Michigan	United States	48084
4	The Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Stryker Instruments

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Instruments
• ClinicalTrials.gov Identifier: NCT00829803
• Other Study ID Numbers: SIS-SNAP-2008-01US
• First Posted: Jan 27, 2009
• Last Update Posted: Nov 9, 2021
• Last Verified: Jun 1, 2011

• Keywords provided by Stryker Instruments: To acquire developmental data to prospectively support SNAP; II index ranges at the studied anesthetic states.

Study Results

No Results Posted as of Nov 9, 2021