NCT00829803

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 9, 2021

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

January 23, 2009

Last Update Submit

November 2, 2021

Conditions

Anesthesia, General

Keywords

To acquire developmental data to prospectively support SNAPII index ranges at the studied anesthetic states.

Outcome Measures

Primary Outcomes (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

Study Arms (2)

SNAP Monitor EEG signals

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

BIS Monitor EEG signals (VISTA)

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

Interventions

SNAP monitor; Bispectral Index Monitor (BIS Monitor)DEVICE

Intended to monitor the state of the brain by data acquisition of EEG signals.

Also known as: SNAP II monitor, BIS Monitor
BIS Monitor EEG signals (VISTA)SNAP Monitor EEG signals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Of Miami

Miami, Florida, 33101-6370, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48084, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Bergese SD, Uribe AA, Puente EG, Marcus RL, Krohn RJ, Docsa S, Soto RG, Candiotti KA. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia. JMIR Res Protoc. 2017 Feb 3;6(2):e15. doi: 10.2196/resprot.6741.

    PMID: 28159731DERIVED

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Sergio D Bergese, M.D.

    Ohio State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 27, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 9, 2021

Record last verified: 2011-06

Locations

US(4)