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PainCVINCT00689130

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

An observational study of Pain, run by Medtronic - MITG at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain
How many people
120 participants
Where
4 sitesin 2 countries
Study dates
May 2008to Oct 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients, aged 18-80, under general anesthesia for a moderately painful elective surgical procedure.

Who may be able to join

  • Age range 18-80 years old
  • ASA I through III
  • Scheduled for elective, non-cardiac surgery under General Anesthesia
  • Ability to understand and perform all recovery assessments and procedures

Who cannot join

  • Subjects with known neurological disorders, including current use of anticonvulsant medications.
  • 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.
  • Patients with any contraindications to the selected anesthetic agents specified for each site.
  • 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.
  • Significant hypotension (systolic BP < 100) or bradycardia (HR < 55) during baseline assessment.
  • Anticipated or planned regional block or extensive local anesthetic for post-operative pain control.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites
  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • University of Louisville

    Louisville, Kentucky, 40202

  • Saint Vincent Catholic Medical Center

    New York, New York, 10011

Other trials in United States

Spain1 site
  • Hospital Sanitas La Moraleja Sanchinarro

    Madrid

Other trials in Spain

About this study

Official title: "Advance": Assessment for Defining Variability in Anesthesia

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).

Read the 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
Keywords
Analgesia, Bispectral Index, BIS Variability, Electroencephalography, Electromyography, Monitoring, Intraoperative, Movement, Pain, Postoperative, Somatic Events, Patients under general anesthesia undergoing a moderately painful procedure.
Medical subject headings
Pain, Agnosia, Pain, Postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00689130
Sponsor's protocol ID
251
Acronym
CVI
Status last verified
Nov 2008
First submitted
30 May 2008
Last updated
7 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Medtronic - MITG at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.

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