ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG

NCT ID: NCT00689130

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-10-31

Brief Summary

The present study is designed to compare prospectively whether sBIS, sEMG, or CVI variability (brain monitoring) can be used to predict unwanted intraoperative responses (high blood pressure, fast heart rate, tearing, etc.) to stimulation (pain) and to determine whether these intraoperative findings are related to patient-assessed postoperative pain scores.

The hypothesis is that increases in these variability measures are associated with increased probability of unwanted responses. If confirmed, these variability measures may help anesthesia providers by highlighting periods of inadequate analgesia (pain relief).

Detailed Description

Anesthesia providers have been using processed EEG parameters (brain monitors) to assess the depth of anesthesia for many years. The Bispectral Index (BIS®; Aspect Medical Systems, Inc.), one such brain monitor, provides a direct measure of the hypnotic state of the patient [1, 2]. These clinicians use the BIS value, a number ranging from 0 (very deep anesthesia) to 100 (awake state), to help optimize anesthetic dosing. Using BIS technology, anesthesia providers may adjust anesthesia doses to provide adequate sedation while avoiding over sedation, resulting in faster recovery [3] and a reduced incidence of awareness with recall [4].

While BIS technology helps anesthesia providers achieve desired levels of hypnosis, they currently rely primarily on monitoring hemodynamic (blood pressure and heart rate), autonomic (tearing, sweating), and somatic (moving) responses to noxious (painful) stimulation as a means to detect potential patient arousals. Additional analgesics (narcotics, NSAIDS) are often administered in order to suppress further response to noxious (painful) stimulation. Several studies have shown that noxious stimulation can also affect EEG signals, resulting in increased variability in the BIS index, suggesting that information in EEG signals could potentially help clinicians anticipate and detect patient response to noxious stimulation.

Ropcke et al. [5] showed that BIS values were higher with surgical stimulation than without any stimulation. Other reports have shown that focal noxious stimuli in volunteers and patients induce transient increases in BIS [6-9]. Many of these studies show that adding analgesics suppresses the BIS response to noxious stimulation, and the level of suppression achieved was related to the dose of the added drugs [6, 8, 9].

Based on these findings, it is expected that insufficient analgesia would likely result in transient increases in BIS due to ongoing surgical stimulation, increasing the overall variability of BIS. Recently reported findings confirm that overall variability of BIS increased prior to and following intraoperative somatic events [10]. These reports also identified similar increases in variability of the EMG, with the largest changes realized from a Composite Variability Index (CVI) which combined the BIS variability (sBIS) and EMG variability (sEMG) into a single value. Other studies have also shown an association between these variability measures and postoperative pain scores [11, 12]. These studies showed that sBIS, sEMG, and CVI computed over the entire surgical procedure were all higher in both adults and children with worse postoperative pain scores. However, the reliability and optimum method of displaying these variability scores has yet to be been determined.

The present study is designed to compare whether sBIS, sEMG, or CVI can be used to predict unwanted intraoperative somatic responses to stimulation, and to determine whether these values are related to patient-assessed postoperative pain scores. Our hypothesis is that increases in these variability measures are associated with increased probability of somatic responses. If our hypothesis is confirmed, these variability measures may help clinicians by highlighting periods of inadequate analgesia.

Conditions

Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age range 18-80 years old

2. ASA I through III

3. Scheduled for elective, non-cardiac surgery under General Anesthesia

4. Ability to understand and perform all recovery assessments and procedures

Exclusion Criteria

1. Subjects with known neurological disorders, including current use of anticonvulsant medications.

2. Subjects with uncontrolled hypertension or other serious medical conditions which would interfere with cardiovascular responses analysis. Subjects on anti-arrhythmics, beta-blockers, or other agents which may reduce the cardiovascular responsiveness to pain and surgical stress.

3. Patients with any contraindications to the selected anesthetic agents specified for each site.

4. Alcohol or illicit drug use which prevents normal functioning in society or has lead to organ toxicity. Chronic use of opioids, narcotics or analgesics which may limit a subject's responsiveness to analgesic dosages.

5. Significant hypotension (systolic BP < 100) or bradycardia (HR < 55) during baseline assessment.

6. Anticipated or planned regional block or extensive local anesthetic for post-operative pain control.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent Catholic Medical Center, New York, New York

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

University of Louisville

Louisville, Kentucky, United States

Saint Vincent Catholic Medical Center

New York, New York, United States

Hospital Sanitas La Moraleja Sanchinarro

Madrid, , Spain

Countries

United States; Spain

Other Identifiers

251

Identifier Type: -

Identifier Source: org_study_id