Use of the SNAP II Electroencephalography (EEG) Monitor in Outpatients Undergoing Surgery/Procedures With Sedation

NCT00204711 | Completed

• 2 other identifiers: H-2005-0014SNAPII
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the SNAP II electroencephalography (EEG) monitor accurately reflects changes in sedation level in outpatients undergoing surgery or procedures with sedation.

Conditions

Sedation

Keywords

patients having outpatient surgery with sedation; patients having procedures with sedation

Outcome Measures

Primary Outcomes (1)

• Assessment of participant heterogeneity between SNAP Index and OASS Score.

  The SNAP Index is a derived EEG (electroencephalogram) parameter (from the SNAP II EEG System) ranging from 100 (completely awake) to 0 (no brain activity). The Observer's Assessment of Alertness/Sedation Score (OASS) is a score derived from motor and sensory functions between 0 and 5 where 0 is unresponsive and 5 is awake.

  up to 1 day post op

Study Arms (1)

Outpatient Surgery with Sedation

SNAP II EEG data will be recorded continuously during the sedation and intermittently compared to routinely monitored parameters of sedation adequacy including vital signs, patient movement, grimacing, verbal complaints, and patient responsiveness to verbal and tactile stimuli. Following surgery, patients will be questioned to determine recall or memory of discomfort.

Other: SNAP II EEG System

Interventions

SNAP II EEG System OTHER

A portable EEG monitor (SNAP II EEG System, Everest -St. Louis) is unique in that it monitors both low frequency EEG signals (1-40 Hz), which are typically used, and high frequency EEG signals (80-420 Hz), which are not usually used, and calculates a derived EEG parameter (the SNAP Index). The SNAP Index ranges from 100 (completely awake) to 0 (no brain activity) and has been shown in a few studies to correlate with increasing sedation and loss of consciousness in human volunteers and patients receiving general anesthesia during surgery.

Outpatient Surgery with Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing outpatient (same day) surgery/procedures with sedation

You may qualify if:

• American Society of Anesthesiologists (ASA) I, II or III physical status

You may not qualify if:

• Use of inhalation general anesthesia
• ASA IV physical status

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Springman SR, Andrei AC, Willmann K, Rusy DA, Warren ME, Han S, Lee M. A comparison of SNAP II and bispectral index monitoring in patients undergoing sedation. Anaesthesia. 2010 Aug;65(8):815-9. doi: 10.1111/j.1365-2044.2010.06408.x. Epub 2010 Jun 25.

  PMID: 20586747 RESULT

Study Officials

• Scott Springman, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (1)